- Monday, September 16, 2024
6:30 AM – 3:00 PM PDT
Speaker Ready Room Hours
6:30 AM – 3:00 PM PDT
Speaker Ready Room Hours
7:00 AM – 4:00 PM PDT
First Aid Hours
7:00 AM – 4:00 PM PDT
First Aid Hours
7:00 AM – 4:00 PM PDT
Registration Hours
7:00 AM – 4:00 PM PDT
Registration Hours
7:30 AM – 8:30 AM PDT
Networking Breakfast & Welcome for Preconference Workshops Registrants
7:30 AM – 8:30 AM PDT
Networking Breakfast & Welcome for Preconference Workshops RegistrantsPreconference Workshops Only
8:30 AM – 4:00 PM PDT
Advanced Leadership Workshop (Day 1 of 2)
8:30 AM – 4:00 PM PDT
Advanced Leadership Workshop (Day 1 of 2)Workshop Leader: – COPIA Leadership
Preconference Workshop
Skill Building
Trista Schoonmaker, PCC – COPIA Leadership ### 593803###Workshop Leader###Partner###COPIA Leadership###Workshop Leader: – COPIA Leadership
### 8:30 AM – 4:00 PM PDT
Artificial Intelligence Enabled Medical Devices: Integrating the AI Act and MDR Requirements in Technical Documentation
8:30 AM – 4:00 PM PDT
Artificial Intelligence Enabled Medical Devices: Integrating the AI Act and MDR Requirements in Technical DocumentationWorkshop Leader: – BSI
Presenter: – BSI
Presenter: – TÜV SÜD Product Service GmbH
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
Sarah Mathew – BSI ### 2177832###Workshop Leader###Regulatory Lead###BSI###Workshop Leader: – BSI
### @@@ Daniela Seneca, MEng (she/her/hers) – BSI ### 2232813###Presenter###Regulatory Lead###BSI###Presenter: – BSI
### she/her/hers @@@ Kenneth Fuh, PhD (he/him/his) – TÜV SÜD Product Service GmbH ### 1947083###Presenter###Senior Product Specialist###TÜV SÜD Product Service GmbH###Presenter: – TÜV SÜD Product Service GmbH
### he/him/his8:30 AM – 4:00 PM PDT
Communicating with Agency Officials, Top Management, and Other Stakeholders for Gaining Alignment on Strategic Initiatives
8:30 AM – 4:00 PM PDT
Communicating with Agency Officials, Top Management, and Other Stakeholders for Gaining Alignment on Strategic InitiativesWorkshop Leader: – Compliance-Alliance, LLC
Presenter: – DeRisio Group, LLC
Presenter: – Johnson & Johnson MedTech, Vision
Preconference Workshop
Other
Nancy Singer, JD, LLM, RAC, FRAPS – Compliance-Alliance, LLC ### 862304###Workshop Leader###President###Compliance-Alliance, LLC###Workshop Leader: – Compliance-Alliance, LLC
### @@@ Richard J. DeRisio, MS (he/him/his) – DeRisio Group, LLC ### 2275466###Presenter###President###DeRisio Group, LLC###Presenter: – DeRisio Group, LLC
### he/him/his @@@ Rosanne M. Melikian, PhD, MSRS, RAC (she/her/hers) – Johnson & Johnson MedTech, Vision ### 2275467###Presenter###Sr. Director Regulatory Affairs###Johnson & Johnson MedTech, Vision###Presenter: – Johnson & Johnson MedTech, Vision
### she/her/hers8:30 AM – 4:00 PM PDT
Drug Development in the EU: Regulatory Standards, Supports, and New Approaches
8:30 AM – 4:00 PM PDT
Drug Development in the EU: Regulatory Standards, Supports, and New ApproachesWorkshop Leader: – Austrian Medicines and Medical Devices Agency
Presenter: – khhconsulting
Presenter: – Gilead Sciences
Presenter: – NDA Partners
Presenter: – AEMPS
Presenter: – European Medicines Agency
Presenter: – Malta Medicines Authority
Preconference Workshop
Biopharmaceuticals (includes Biologics and Drugs)
Andrea Laslop, MD (she/her/hers) – Austrian Medicines and Medical Devices Agency ### 573431###Workshop Leader###Head of Scientific Office###Austrian Medicines and Medical Devices Agency###Workshop Leader: – Austrian Medicines and Medical Devices Agency
### she/her/hers @@@ Karl-Heinz Huemer (he/him/his) – khhconsulting ### 573393###Presenter###Consultant###khhconsulting###Presenter: – khhconsulting
### he/him/his @@@ Sue Liu, B.Eng (pharm) MBA RAC – Gilead Sciences ### 2275671###Presenter###Executive Director, Quality###Gilead Sciences###Presenter: – Gilead Sciences
### @@@ Daniela Drago, RAC, FRAPS – NDA Partners ### 2275468###Presenter###Partner###NDA Partners###Presenter: – NDA Partners
### @@@ Maria Concepción Prieto Yerro, MD, PhD – AEMPS ### 790292###Presenter###ex-CHMP member###AEMPS###Presenter: – AEMPS
### @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Presenter###Principal Scientific Administrator###European Medicines Agency###Presenter: – European Medicines Agency
### @@@ John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority ### 1757708###Presenter###Post-Licensing Director###Malta Medicines Authority###Presenter: – Malta Medicines Authority
### 8:30 AM – 4:00 PM PDT
Failure Is Not An Option: How to Avoid and Recover From an IND Clinical Hold
8:30 AM – 4:00 PM PDT
Failure Is Not An Option: How to Avoid and Recover From an IND Clinical HoldPresenter: – IAA Consulting LLC
Presenter: – UCB Biopharma
Presenter: – Amylaza Consulting, LLC
Presenter:
Presenter: – ORMRR/OTP/CBER/FDA
Preconference Workshop
Biopharmaceuticals (includes Biologics and Drugs)
Linda McBride, R.Ph., RAC – IAA Consulting LLC ### 1946958###Presenter###Partner###IAA Consulting LLC###Presenter: – IAA Consulting LLC
### @@@ Tyler C. Vandivort, PhD, RAC, DABT (he/him/his) – UCB Biopharma ### 1546697###Presenter###Associate Director, Regulatory Affairs Lead###UCB Biopharma###Presenter: – UCB Biopharma
### he/him/his @@@ Ben McLaughlin, MSE – Amylaza Consulting, LLC ### 2338737###Presenter###Principal Consultant###Amylaza Consulting, LLC###Presenter: – Amylaza Consulting, LLC
### @@@ Maureen Dillion Parker ### 2364482###Presenter#########Presenter:
### @@@ Ramani Sista, PhD (she/her/hers) – ORMRR/OTP/CBER/FDA ### 2045330###Presenter###Director###ORMRR/OTP/CBER/FDA###Presenter: – ORMRR/OTP/CBER/FDA
### she/her/hers8:30 AM – 4:00 PM PDT
IVDR Technical Documentation Workshop
8:30 AM – 4:00 PM PDT
IVDR Technical Documentation WorkshopPresenter: – TUV Sud GmbH
Presenter: – GMED
Presenter: – GMED
Presenter: – BSI
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Presenter###Head of Certification IVD###TUV Sud GmbH###Presenter: – TUV Sud GmbH
### @@@ Tom Patten, MSc – GMED ### 1141749###Presenter###IVDR/IVD International Manager###GMED###Presenter: – GMED
### @@@ Catherine Holzmann, PhD – GMED ### 1828311###Presenter###IVD Department Manager###GMED###Presenter: – GMED
### @@@ Alex Laan (he/him/his) – BSI ### 1945990###Presenter###Head of IVD Notified Body###BSI###Presenter: – BSI
### he/him/his8:30 AM – 4:00 PM PDT
Sharpening Your Regulatory Soft Skills Toolbox
8:30 AM – 4:00 PM PDT
Sharpening Your Regulatory Soft Skills ToolboxPresenter: – Wolters Kluwer UpToDate, Inc.
Presenter: – Lumos Diagnostics
Presenter: – Regulatory Affairs Professionals Society (RAPS)
Preconference Workshop
Skill Building
Susan Speicher, MS, RAC (she/her/hers) – Wolters Kluwer UpToDate, Inc. ### 1976561###Presenter###Director, Reglatory Affairs and Quality Compliance###Wolters Kluwer UpToDate, Inc.###Presenter: – Wolters Kluwer UpToDate, Inc.
### she/her/hers @@@ Sue Hibbeln, MS, RAC – Lumos Diagnostics ### 1523596###Presenter###VP###Lumos Diagnostics###Presenter: – Lumos Diagnostics
### @@@ Bill McMoil, MBA – Regulatory Affairs Professionals Society (RAPS) ### 1083161###Presenter###RAPS Executive Director###Regulatory Affairs Professionals Society (RAPS)###Presenter: – Regulatory Affairs Professionals Society (RAPS)
### 8:30 AM – 4:00 PM PDT
Survivor: The FDA 510(k) Program Edition (Day 1 of 2)
8:30 AM – 4:00 PM PDT
Survivor: The FDA 510(k) Program Edition (Day 1 of 2)Presenter: – DuVal & Associates, P.A.
Presenter: – DuVal & Associates, P.A.
Presenter: – DuVal & Associates, P.A.
Presenter: – RQM+
Presenter: – Galvanize Therapeutics
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
Mark E. DuVal, JD, FRAPS – DuVal & Associates, P.A. ### 535473###Presenter###President & CEO###DuVal & Associates, P.A.###Presenter: – DuVal & Associates, P.A.
### @@@ Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A. ### 1614391###Presenter###VP, Regulatory, Quality, Clinical & Engineering###DuVal & Associates, P.A.###Presenter: – DuVal & Associates, P.A.
### @@@ Kathy Herzog, BSME – DuVal & Associates, P.A. ### 1614392###Presenter###Sr. Regulatory, Quality and Compliance Consultant###DuVal & Associates, P.A.###Presenter: – DuVal & Associates, P.A.
### @@@ Allison Komiyama, PhD, RAC (she/her/hers) – RQM+ ### 1631717###Presenter###VP, MedTech Innovations###RQM+###Presenter: – RQM+
### she/her/hers @@@ Dongbo Wang – Galvanize Therapeutics ### 1949304###Presenter######Galvanize Therapeutics###Presenter: – Galvanize Therapeutics
### 10:30 AM – 11:00 AM PDT
Networking Break for Preconference Workshops Registrants
10:30 AM – 11:00 AM PDT
Networking Break for Preconference Workshops RegistrantsPreconference Workshops Only
12:30 PM – 1:30 PM PDT
Networking Lunch for Preconference Workshops Registrants
12:30 PM – 1:30 PM PDT
Networking Lunch for Preconference Workshops RegistrantsPreconference Workshops Only
3:00 PM – 3:15 PM PDT
Afternoon Break for Preconference Workshops Registrants
3:00 PM – 3:15 PM PDT
Afternoon Break for Preconference Workshops RegistrantsPreconference Workshops Only
- Tuesday, September 17, 2024
6:30 AM – 4:30 PM PDT
Speaker Ready Room Hours
6:30 AM – 4:30 PM PDT
Speaker Ready Room Hours
7:00 AM – 7:30 PM PDT
First Aid Hours
7:00 AM – 7:30 PM PDT
First Aid Hours
7:00 AM – 7:30 PM PDT
Registration Hours
7:00 AM – 7:30 PM PDT
Registration Hours
7:30 AM – 8:30 AM PDT
Networking Breakfast & Welcome for Preconference Workshops Registrants
7:30 AM – 8:30 AM PDT
Networking Breakfast & Welcome for Preconference Workshops RegistrantsPreconference Workshops Only
8:30 AM – 4:00 PM PDT
Advanced Leadership Workshop (Day 2 of 2)
8:30 AM – 4:00 PM PDT
Advanced Leadership Workshop (Day 2 of 2)Workshop Leader: – COPIA Leadership
Preconference Workshop
Skill Building
Trista Schoonmaker, PCC – COPIA Leadership ### 593803###Workshop Leader###Partner###COPIA Leadership###Workshop Leader: – COPIA Leadership
### 8:30 AM – 4:00 PM PDT
Basics of Regulatory Strategy for the US & EU
8:30 AM – 4:00 PM PDT
Basics of Regulatory Strategy for the US & EUPresenter: – nexialist
Presenter: – Philips
Presenter: – Veeva Systems
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
Corinne Delorme, RAC – nexialist ### 1523467###Presenter###Regulatory Intelligence Director###nexialist###Presenter: – nexialist
### @@@ Josh Silverstein, PhD (he/him/his) – Philips ### 2311833###Presenter###Director###Philips###Presenter: – Philips
### he/him/his @@@ Ayesha Shah – Veeva Systems ### 2394738###Presenter###Director of Regulatory Strategy###Veeva Systems###Presenter: – Veeva Systems
### 8:30 AM – 4:00 PM PDT
Maximizing Opportunities to Engage with the FDA
8:30 AM – 4:00 PM PDT
Maximizing Opportunities to Engage with the FDAWorkshop Leader: – BioMarin Pharmaceuticals, Inc.
Workshop Leader: – Division of Regulatory Operations and Programs / Office of Regulatory Operations / Center for Biologics Evaluation and Research / Food and Drug Administration
Presenter: – BOLDAPPROVALS
Presenter: – FDA/CDER
Presenter: – ORMRR/OTP/CBER/FDA
Preconference Workshop
Biopharmaceuticals (includes Biologics and Drugs)
Jewell Martin, MA, MBA, PMP, RAC (she/her/hers) – BioMarin Pharmaceuticals, Inc. ### 1946971###Workshop Leader###Director for US Regulatory Policy###BioMarin Pharmaceuticals, Inc.###Workshop Leader: – BioMarin Pharmaceuticals, Inc.
### she/her/hers @@@ Sonday L. Kelly, MS, RAC, PMP – Division of Regulatory Operations and Programs / Office of Regulatory Operations / Center for Biologics Evaluation and Research / Food and Drug Administration ### 1679212###Workshop Leader###Director###Division of Regulatory Operations and Programs / Office of Regulatory Operations / Center for Biologics Evaluation and Research / Food and Drug Administration###Workshop Leader: – Division of Regulatory Operations and Programs / Office of Regulatory Operations / Center for Biologics Evaluation and Research / Food and Drug Administration
### @@@ Angela W. Corona, PhD – BOLDAPPROVALS ### 2278485###Presenter###Senior Scientific Director###BOLDAPPROVALS###Presenter: – BOLDAPPROVALS
### @@@ Christy Cottrell – FDA/CDER ### 2057618###Presenter###Chief Project Manager###FDA/CDER###Presenter: – FDA/CDER
### @@@ Ramani Sista, PhD (she/her/hers) – ORMRR/OTP/CBER/FDA ### 2045330###Presenter###Director###ORMRR/OTP/CBER/FDA###Presenter: – ORMRR/OTP/CBER/FDA
### she/her/hers8:30 AM – 4:00 PM PDT
MDR Surveillance, Post-Certification and Re-certification submissions to Notified Bodies: Best Practice for Manufacturers.
8:30 AM – 4:00 PM PDT
MDR Surveillance, Post-Certification and Re-certification submissions to Notified Bodies: Best Practice for Manufacturers.Workshop Leader: – BSI
Presenter: – BSI
Presenter: – BSI
Presenter: – DNV Product Assurance AS
Presenter: – LNE-GMED-UK
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
Purvi S. Patel, PhD CEng (she/her/hers) – BSI ### 1950306###Workshop Leader###Regulatory Lead###BSI###Workshop Leader: – BSI
### she/her/hers @@@ Rachel Mead, BEng MIET (she/her/hers) – BSI ### 2016362###Presenter###Clinical Regulatory Lead###BSI###Presenter: – BSI
### she/her/hers @@@ Vishal Thakker, MEng (he/him/his) – BSI ### 1614543###Presenter###Head of the UK Approved Body###BSI###Presenter: – BSI
### he/him/his @@@ Alexey Shiryaev, MD PhD – DNV Product Assurance AS ### 1645653###Presenter###Global Head of Clinical and Regulatory Affairs###DNV Product Assurance AS###Presenter: – DNV Product Assurance AS
### @@@ Duncan McPherson, MBBS FRCA (he/him/his) – LNE-GMED-UK ### 844201###Presenter###Internal Clinician###LNE-GMED-UK###Presenter: – LNE-GMED-UK
### he/him/his8:30 AM – 4:00 PM PDT
Practical Aspects of Building Real World Evidence Strategy for Medical Devices Regulatory Submissions
8:30 AM – 4:00 PM PDT
Practical Aspects of Building Real World Evidence Strategy for Medical Devices Regulatory SubmissionsWorkshop Leader: – NA
Presenter: – BSI
Presenter: – Aetion
Presenter: – FDA CDRH
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
Estelle Frappe (she/her/hers) – NA ### 2177814###Workshop Leader###Director RWE MD&D###NA###Workshop Leader: – NA
### she/her/hers @@@ Richard G. Holborow (he/him/his) – BSI ### 1054191###Presenter###Global Head of Clinical Compliance###BSI###Presenter: – BSI
### he/him/his @@@ Wendy Turenne, MS – Aetion ### 2275465###Presenter###SVP, Real World Data ###Aetion###Presenter: – Aetion
### @@@ Felipe Aguel – FDA CDRH ### 2275469###Presenter###Deputy Director, Office of Clinical Evidence and Analysis###FDA CDRH###Presenter: – FDA CDRH
### 8:30 AM – 4:00 PM PDT
Strategy and Regulatory Intelligence (RI) Primer: How to construct and maintain it using AI Tools
8:30 AM – 4:00 PM PDT
Strategy and Regulatory Intelligence (RI) Primer: How to construct and maintain it using AI ToolsPresenter: – Regulatorium
Presenter: – Recursion Pharmaceuticals, Inc.
Preconference Workshop
Skill Building
Meredith Brown-Tuttle, FRAPS – Regulatorium ### 535518###Presenter###Chief Regulatory Strategist###Regulatorium###Presenter: – Regulatorium
### @@@ Jay H. Mashburn, PhD, RPh (he/him/his) – Recursion Pharmaceuticals, Inc. ### 2275470###Presenter###Director of Regulatory Policy and Intelligence###Recursion Pharmaceuticals, Inc.###Presenter: – Recursion Pharmaceuticals, Inc.
### he/him/his8:30 AM – 4:00 PM PDT
Survivor: The FDA 510(k) Program Edition (Day 2 of 2)
8:30 AM – 4:00 PM PDT
Survivor: The FDA 510(k) Program Edition (Day 2 of 2)Presenter: – DuVal & Associates, P.A.
Presenter: – DuVal & Associates, P.A.
Presenter: – DuVal & Associates, P.A.
Presenter: – RQM+
Presenter: – Galvanize Therapeutics
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
Mark E. DuVal, JD, FRAPS – DuVal & Associates, P.A. ### 535473###Presenter###President & CEO###DuVal & Associates, P.A.###Presenter: – DuVal & Associates, P.A.
### @@@ Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A. ### 1614391###Presenter###VP, Regulatory, Quality, Clinical & Engineering###DuVal & Associates, P.A.###Presenter: – DuVal & Associates, P.A.
### @@@ Kathy Herzog, BSME – DuVal & Associates, P.A. ### 1614392###Presenter###Sr. Regulatory, Quality and Compliance Consultant###DuVal & Associates, P.A.###Presenter: – DuVal & Associates, P.A.
### @@@ Allison Komiyama, PhD, RAC (she/her/hers) – RQM+ ### 1631717###Presenter###VP, MedTech Innovations###RQM+###Presenter: – RQM+
### she/her/hers @@@ Dongbo Wang – Galvanize Therapeutics ### 1949304###Presenter######Galvanize Therapeutics###Presenter: – Galvanize Therapeutics
### 10:30 AM – 11:00 AM PDT
Networking Break for Preconference Workshops Registrants
10:30 AM – 11:00 AM PDT
Networking Break for Preconference Workshops RegistrantsPreconference Workshops Only
12:30 PM – 1:30 PM PDT
Networking Lunch for Preconference Workshops Registrants
12:30 PM – 1:30 PM PDT
Networking Lunch for Preconference Workshops RegistrantsPreconference Workshops Only
2:30 PM – 3:30 PM PDT
Career Development Session for Students
2:30 PM – 3:30 PM PDT
Career Development Session for Students
3:00 PM – 3:15 PM PDT
Afternoon Break for Preconference Workshops Registrants
3:00 PM – 3:15 PM PDT
Afternoon Break for Preconference Workshops RegistrantsPreconference Workshops Only
4:30 PM – 6:00 PM PDT
RAPS Convergence 2024 Welcome and Opening Plenary
4:30 PM – 6:00 PM PDT
RAPS Convergence 2024 Welcome and Opening Plenary
6:00 PM – 7:30 PM PDT
Opening Reception in the Exhibit Hall
6:00 PM – 7:30 PM PDT
Opening Reception in the Exhibit Hall
- Wednesday, September 18, 2024
6:30 AM – 5:00 PM PDT
Speaker Ready Room Hours
6:30 AM – 5:00 PM PDT
Speaker Ready Room Hours
6:30 AM – 5:30 PM PDT
First Aid Hours
6:30 AM – 5:30 PM PDT
First Aid Hours
6:30 AM – 5:30 PM PDT
Registration Hours
6:30 AM – 5:30 PM PDT
Registration Hours
7:00 AM – 8:00 AM PDT
Community Gathering & Continental Breakfast
7:00 AM – 8:00 AM PDT
Community Gathering & Continental Breakfast
8:00 AM – 9:00 AM PDT
RAPS Convergence 2024 Morning Plenary Session
8:00 AM – 9:00 AM PDT
RAPS Convergence 2024 Morning Plenary Session
9:15 AM – 10:30 AM PDT
Addressing Medicines Shortages in EU: Prevent, Mitigate, and Ensure Visibility
9:15 AM – 10:30 AM PDT
Addressing Medicines Shortages in EU: Prevent, Mitigate, and Ensure VisibilityBiopharmaceuticals (includes Biologics and Drugs)
Romain Kherrat, PharmD (he/him/his) – Clarivate ### 2275438###Presenter###Senior Regulatory Solution Consultant - PharmD###Clarivate###Presenter: – Clarivate
### he/him/his9:15 AM – 10:30 AM PDT
Future State of Europe
9:15 AM – 10:30 AM PDT
Future State of EuropeDevices (includes Medical Devices and In Vitro Diagnostics)
9:15 AM – 10:30 AM PDT
Health Authority Forum: European Medicines Agency (EMA)
9:15 AM – 10:30 AM PDT
Health Authority Forum: European Medicines Agency (EMA)Presenter: – European Medicines Agency
Health Authority Session
Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Presenter###Principal Scientific Administrator###European Medicines Agency###Presenter: – European Medicines Agency
### 9:15 AM – 10:30 AM PDT
Increasing consumer/patient access, engagement and health equity: Innovation leveraging FDA proposed/new ACNU NDA regulatory pathway
9:15 AM – 10:30 AM PDT
Increasing consumer/patient access, engagement and health equity: Innovation leveraging FDA proposed/new ACNU NDA regulatory pathwaySession Leader: – Klick Health, LLC
Presenter: – Haleon
Presenter: – FDA
Presenter: – FDA
Biopharmaceuticals (includes Biologics and Drugs)
Paul A. Wardle, MA, MMath – Klick Health, LLC ### 1615713###Session Leader###SVP, Innovation Consulting###Klick Health, LLC###Session Leader: – Klick Health, LLC
### @@@ Erin Oliver, MS, MBA, FRAPS – Haleon ### 1007343###Presenter###VP Regulatory Affairs###Haleon###Presenter: – Haleon
### @@@ Elisabeth Walther, PharmD, JD (she/her/hers) – FDA ### 2057616###Presenter###Associate Director for Strategic Initiatives###FDA###Presenter: – FDA
### she/her/hers @@@ Danielle Terrell, PharmD, JD, MS, RAC-US – FDA ### 2057617###Presenter###Associate Director for Strategic Initiatives###FDA###Presenter: – FDA
### 9:15 AM – 10:30 AM PDT
International Harmonization
9:15 AM – 10:30 AM PDT
International HarmonizationDevices (includes Medical Devices and In Vitro Diagnostics)
9:15 AM – 10:30 AM PDT
Progress Towards Unlocking Opportunities for Entry-Level Positions in Regulatory Affairs
9:15 AM – 10:30 AM PDT
Progress Towards Unlocking Opportunities for Entry-Level Positions in Regulatory AffairsSession Leader: – Alexion, AstraZeneca Rare Disease
Presenter: – Regulatory Affairs Professionals Society (RAPS)
Presenter: – Network Partners Group (NPG)
Presenter: – University of Georgia
Presenter: – Elemed
Skill Building
Jethro Ekuta, DVM, PhD, RAC, FRAPS – Alexion, AstraZeneca Rare Disease ### 1698806###Session Leader###Vice President, Regulatory Affairs###Alexion, AstraZeneca Rare Disease###Session Leader: – Alexion, AstraZeneca Rare Disease
### @@@ Brian Savoie (he/him/his) – Regulatory Affairs Professionals Society (RAPS) ### 1967174###Presenter###Sr. Vice President, Education & International Programs###Regulatory Affairs Professionals Society (RAPS)###Presenter: – Regulatory Affairs Professionals Society (RAPS)
### he/him/his @@@ Ritu Dhami – Network Partners Group (NPG) ### 1967175###Presenter###Chief of Staff - Strategic Initiatives###Network Partners Group (NPG)###Presenter: – Network Partners Group (NPG)
### @@@ Grace Gowda, M.Pharm., PhD, RAC – University of Georgia ### 2009083###Presenter###Director, International Biomedical Regulatory Sciences Program, Assoc. Professor, Coll. of Pharmacy###University of Georgia###Presenter: – University of Georgia
### @@@ Parminder Kalle, BSc (Hons), Dip Prof Skills – Elemed ### 2313223###Presenter###Senior Director, Strategic Solutions###Elemed###Presenter: – Elemed
### 9:15 AM – 10:30 AM PDT
Standardization of Clinical Study Design
9:15 AM – 10:30 AM PDT
Standardization of Clinical Study DesignPresenter: – MD-CLINICALS SA
Presenter: – DNV Product Assurance AS
Devices (includes Medical Devices and In Vitro Diagnostics)
Danielle Giroud, MSci, MBA (she/her/hers) – MD-CLINICALS SA ### 1187621###Presenter###Founder and CEO###MD-CLINICALS SA###Presenter: – MD-CLINICALS SA
### she/her/hers @@@ DIane Legere, RN, BSN, MSc, APCCN – DNV Product Assurance AS ### 2408285###Presenter###Clinical Evaluation Specialist for medical devices###DNV Product Assurance AS###Presenter: – DNV Product Assurance AS
### 9:15 AM – 10:30 AM PDT
Using Innovative Regulatory Strategies to Streamline Drug Development – Real World Evidence, Platform Trials and Seamless Designs
9:15 AM – 10:30 AM PDT
Using Innovative Regulatory Strategies to Streamline Drug Development – Real World Evidence, Platform Trials and Seamless DesignsSession Leader: – Fairmount Funds Management
Presenter:
Biopharmaceuticals (includes Biologics and Drugs)
Michelle Pernice, Pharm.D. – Fairmount Funds Management ### 2363794###Session Leader###Operating Partner###Fairmount Funds Management ###Session Leader: – Fairmount Funds Management
### @@@ Chelsea O’Connell, MS, RAC ### 2393140###Presenter#########Presenter:
### 10:30 AM – 1:00 PM PDT
Presentations & Networking in Exhibit Hall
10:30 AM – 1:00 PM PDT
Presentations & Networking in Exhibit HallNetworking Opportunity
Exhibit Hall
10:30 AM – 4:30 PM PDT
Exhibit Hall Hours
10:30 AM – 4:30 PM PDT
Exhibit Hall HoursExhibit Hall
10:35 AM – 11:05 AM PDT
How to Prepare for a Successful FDA Q-sub
10:35 AM – 11:05 AM PDT
How to Prepare for a Successful FDA Q-subExhibit Hall: Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Lucy Tan (she/her/hers) – Abbott ### 1945627###Facilitator###Senior Director Regulatory Affairs###Abbott###Facilitator: – Abbott
### she/her/hers10:35 AM – 11:05 AM PDT
Is this AI/ML Software Application a Medical device? Applying FDA Guidance Documents and On-Line Resources
10:35 AM – 11:05 AM PDT
Is this AI/ML Software Application a Medical device? Applying FDA Guidance Documents and On-Line ResourcesFacilitator: – Beckman Coulter
Exhibit Hall: Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Alex Friedman, PhD, RAC – Beckman Coulter ### 2275540###Facilitator###Staff Regulatory Affairs Specialist###Beckman Coulter###Facilitator: – Beckman Coulter
### 10:35 AM – 11:05 AM PDT
Leveraging Dual RAC certification; Become an Expert in Enhancing the Success of Combination Product Development.
10:35 AM – 11:05 AM PDT
Leveraging Dual RAC certification; Become an Expert in Enhancing the Success of Combination Product Development.Facilitator: – Veristat Inc
Exhibit Hall: Solutions Circle
Other
Charles Nnabuife, B.Pharm, MBA, RAC-Drugs – Veristat Inc ### 2275541###Facilitator###Associate Project Manager, Regulatory Affairs###Veristat Inc###Facilitator: – Veristat Inc
### 10:35 AM – 11:05 AM PDT
Maximizing the Potential of Meetings with the FDA
10:35 AM – 11:05 AM PDT
Maximizing the Potential of Meetings with the FDAFacilitator: – HMC-regulation; Dr. Hagit Marchaim RA and Drug Development Consulting
Exhibit Hall: Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Hagit Marchaim, PhD (she/her/hers) – HMC-regulation; Dr. Hagit Marchaim RA and Drug Development Consulting ### 1947145###Facilitator###Owner and principal consultant ###HMC-regulation; Dr. Hagit Marchaim RA and Drug Development Consulting###Facilitator: – HMC-regulation; Dr. Hagit Marchaim RA and Drug Development Consulting
### she/her/hers10:45 AM – 11:10 AM PDT
Sponsored Presentation in the Discover Theater
10:45 AM – 11:10 AM PDT
Sponsored Presentation in the Discover Theater
10:45 AM – 11:10 AM PDT
Sponsored Presentation: Celegence
10:45 AM – 11:10 AM PDT
Sponsored Presentation: Celegence
10:45 AM – 11:10 AM PDT
Sponsored Presentation: Revolutionizing Life Science Recalls
10:45 AM – 11:10 AM PDT
Sponsored Presentation: Revolutionizing Life Science Recalls
Zillery A. Fortner – Honeywell ### 2410215###Speaker###Industry Business Development Director, SME###Honeywell###Speaker: – Honeywell
### 11:10 AM – 11:40 AM PDT
Evaluating the Quality of Real-World Evidence Used to Support Regulatory Decision-Making for Medical Devices
11:10 AM – 11:40 AM PDT
Evaluating the Quality of Real-World Evidence Used to Support Regulatory Decision-Making for Medical DevicesFacilitator: – Johnson and Johnson
Exhibit Hall: Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Michelle Kavin, PhD, PA-C (she/her/hers) – Johnson and Johnson ### 2275536###Facilitator###Clinical Research Leader###Johnson and Johnson###Facilitator: – Johnson and Johnson
### she/her/hers11:10 AM – 11:40 AM PDT
Strategies on tackling Clinical Data Gaps between Different Designs of Medical Devices
11:10 AM – 11:40 AM PDT
Strategies on tackling Clinical Data Gaps between Different Designs of Medical DevicesFacilitator: – Akra Team Inc.
Exhibit Hall: Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Matthias Fink, MD – Akra Team Inc. ### 1945993###Facilitator###Senior Clinical Consultant###Akra Team Inc.###Facilitator: – Akra Team Inc.
### 11:10 AM – 11:40 AM PDT
The Right Balance Between Business, Science, and Regulation in Managing Supply Chains
11:10 AM – 11:40 AM PDT
The Right Balance Between Business, Science, and Regulation in Managing Supply ChainsFacilitator: – Biohaven Pharmaceuticals
Exhibit Hall: Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Lopa Bakrania, PhD, RAC – Biohaven Pharmaceuticals ### 2275548###Facilitator###Executive Director, Head of CMC Regulatory Affairs###Biohaven Pharmaceuticals###Facilitator: – Biohaven Pharmaceuticals
### 11:15 AM – 11:50 AM PDT
Sponsored Presentation in the Discover Theater
11:15 AM – 11:50 AM PDT
Sponsored Presentation in the Discover Theater
11:15 AM – 11:50 AM PDT
Sponsored Presentation in the Ignite Theater
11:15 AM – 11:50 AM PDT
Sponsored Presentation: Optimizing Health Authority interaction outcomes using an integrated strategy and multidisciplinary global regulatory and product development teamSpeaker: – Allucent
Speaker: – Allucent
Speaker: – Allucent
Nadine Bouchard, B.Sc. – Allucent ### 2410221###Speaker###VP, Regulatory Affairs, Head of Program Management###Allucent###Speaker: – Allucent
### @@@ Sheila Plant, PhD, MHS, RAC – Allucent ### 2410222###Speaker###Senior Director, Regulatory Affairs###Allucent###Speaker: – Allucent
### @@@ Joshua Taylor, PhD, RAC – Allucent ### 2410223###Speaker###Senior Director, Regulatory Affairs###Allucent###Speaker: – Allucent
### 11:15 AM – 11:50 AM PDT
Sponsored Presentation in the Spark Theater
11:15 AM – 11:50 AM PDT
Sponsored Presentation: A Breakthrough Approach to PMCF; Reducing Time, Cost and Risk
Amelia Hufford, PhD – 3Aware ### 2410217###Speaker###Senior Vice President of Clinical and Regulatory Science###3Aware###Speaker: – 3Aware
### 11:30 AM – 1:00 PM PDT
Networking Lunch in the Exhibit Hall
11:30 AM – 1:00 PM PDT
Networking Lunch in the Exhibit HallNetworking Opportunity
Exhibit Hall
11:45 AM – 12:15 PM PDT
Career Pathways in Regulatory Affairs
11:45 AM – 12:15 PM PDT
Career Pathways in Regulatory AffairsExhibit Hall: Solutions Circle
Other
Jay Patel, MS – KPMG ### 1321688###Facilitator###Director, Life Sciences Advisory###KPMG###Facilitator: – KPMG
### 11:45 AM – 12:15 PM PDT
Establishing a Regulatory Talent Pipeline Strategy for Industry 4.0
11:45 AM – 12:15 PM PDT
Establishing a Regulatory Talent Pipeline Strategy for Industry 4.0Exhibit Hall: Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Filsun Moussa, MBA, PMP – Medtronic ### 2275546###Facilitator###Sr. Regulatory Affairs Manager###Medtronic###Facilitator: – Medtronic
### 11:45 AM – 12:15 PM PDT
Phase and Product Appropriate Regulatory Strategies in Impurity Characterizations and Controls
11:45 AM – 12:15 PM PDT
Phase and Product Appropriate Regulatory Strategies in Impurity Characterizations and ControlsFacilitator: – El Vista Consulting LLC
Exhibit Hall: Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Hai Wang, PhD (he/him/his) – El Vista Consulting LLC ### 2275539###Facilitator###Managing Director###El Vista Consulting LLC###Facilitator: – El Vista Consulting LLC
### he/him/his11:45 AM – 12:15 PM PDT
Post-Market 510(k) and De Novo Change Management: Cinderella Strategies for Keeping Your House in Order
11:45 AM – 12:15 PM PDT
Post-Market 510(k) and De Novo Change Management: Cinderella Strategies for Keeping Your House in OrderFacilitator: – DuVal & Associates, P.A.
Exhibit Hall: Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Kathy Herzog, BSME – DuVal & Associates, P.A. ### 1614392###Facilitator###Sr. Regulatory, Quality and Compliance Consultant###DuVal & Associates, P.A.###Facilitator: – DuVal & Associates, P.A.
### 11:55 AM – 12:20 PM PDT
Sponsored Presentation in the Discover Theater
11:55 AM – 12:20 PM PDT
Sponsored Presentation in the Discover Theater
11:55 AM – 12:20 PM PDT
Sponsored Presentation in the Spark Theater
11:55 AM – 12:20 PM PDT
Sponsored Presentation in the Spark Theater
11:55 AM – 12:20 PM PDT
Sponsored Presentation: Commercializing a Medical Device: Where to Start?
11:55 AM – 12:20 PM PDT
Sponsored Presentation: Commercializing a Medical Device: Where to Start?Speaker: – Biologics Consulting Group, Inc.
Speaker: – Biologics Consulting Group, Inc.
Matthew Krueger, M.S., RAC (U.S.) – Biologics Consulting Group, Inc. ### 2410219###Speaker###Sr. Consultant###Biologics Consulting Group, Inc.###Speaker: – Biologics Consulting Group, Inc.
### @@@ Maddie Golding – Biologics Consulting Group, Inc. ### 2410220###Speaker###Consultant###Biologics Consulting Group, Inc.###Speaker: – Biologics Consulting Group, Inc.
### 12:20 PM – 12:50 PM PDT
LDT, RUO, IVD: What Regulatory Status for Tests Used in European Clinical Trial?
12:20 PM – 12:50 PM PDT
LDT, RUO, IVD: What Regulatory Status for Tests Used in European Clinical Trial?Exhibit Hall: Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Christèle East (she/her/hers) – Namsa ### 1828312###Facilitator###Senior Regulatory Consultant, IVD###Namsa###Facilitator: – Namsa
### she/her/hers12:20 PM – 12:50 PM PDT
Orphan Drug Approval FDA / EMA - What are the Benefits? What is the Process?
12:20 PM – 12:50 PM PDT
Orphan Drug Approval FDA / EMA - What are the Benefits? What is the Process?Facilitator: – Team Consulting
Exhibit Hall: Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Mark A. Di Cioccio – Team Consulting ### 958556###Facilitator###Managing Consultant QA/RA###Team Consulting###Facilitator: – Team Consulting
### 12:25 PM – 12:50 PM PDT
Sponsored Presentation in the Discover Theater
12:25 PM – 12:50 PM PDT
Sponsored Presentation in the Discover Theater
12:25 PM – 12:50 PM PDT
Sponsored Presentation in the Ignite Theater
12:25 PM – 12:50 PM PDT
Sponsored Presentation in the Ignite Theater
12:25 PM – 12:50 PM PDT
Sponsored Presentation in the Spark Theater
12:25 PM – 12:50 PM PDT
Sponsored Presentation in the Spark Theater
1:00 PM – 2:00 PM PDT
CDER’s Product Quality Review of Biologics & Biosimilars: Common Findings, Review Issues and Post-marketing Recommendations
1:00 PM – 2:00 PM PDT
CDER’s Product Quality Review of Biologics & Biosimilars: Common Findings, Review Issues and Post-marketing RecommendationsPresenter: – Visterra, Inc
Presenter: – Visterra, Inc
Presenter: – Visterra, Inc
Biopharmaceuticals (includes Biologics and Drugs)
Kelly Nolan, MS (she/her/hers) – Visterra, Inc ### 2275687###Presenter###Senior Manager, Regulatory Affairs###Visterra, Inc###Presenter: – Visterra, Inc
### she/her/hers @@@ William Tubbs – Visterra, Inc ### 2275686###Presenter###Vice President and Head of Regulatory Affairs###Visterra, Inc###Presenter: – Visterra, Inc
### @@@ Tulay Kilicdagi, MA, RAC-Drugs – Visterra, Inc ### 2275685###Presenter###Associate Director, Regulatory Affairs###Visterra, Inc###Presenter: – Visterra, Inc
### 1:00 PM – 2:00 PM PDT
Conversations That Matter - Interactions with Health Authorities: Drugs, Biologics and Combination Products
1:00 PM – 2:00 PM PDT
Conversations That Matter - Interactions with Health Authorities: Drugs, Biologics and Combination ProductsHealth Authority Session
1:00 PM – 2:00 PM PDT
Digital Labeling and eIFU Enhance Customer Experience, Facilitate Compliance, and Improve Operational Efficiencies and Agility
1:00 PM – 2:00 PM PDT
Digital Labeling and eIFU Enhance Customer Experience, Facilitate Compliance, and Improve Operational Efficiencies and AgilityPresenter:
Presenter: – Johnson & Johnson Medtech
Devices (includes Medical Devices and In Vitro Diagnostics)
Nataliya Deych ### 2016357###Presenter#########Presenter:
### @@@ Glenda Marsh (she/her/hers) – Johnson & Johnson Medtech ### 2322922###Presenter###Sr. Director, EMEA Regulatory Afairs###Johnson & Johnson Medtech###Presenter: – Johnson & Johnson Medtech
### she/her/hers1:00 PM – 2:00 PM PDT
Examining Methods to Ensure Data Quality and Privacy Considerations for AI-Enabled Medical Devices
1:00 PM – 2:00 PM PDT
Examining Methods to Ensure Data Quality and Privacy Considerations for AI-Enabled Medical DevicesSession Leader: – TPIreg, a Division of Innomar Strategies Inc.
Presenter: – be-on-Quality GmbH
Devices (includes Medical Devices and In Vitro Diagnostics)
Shirley Furesz, PhD, RAC – TPIreg, a Division of Innomar Strategies Inc. ### 2408374###Session Leader###Director, Regulatory Affairs Medical Devices###TPIreg, a Division of Innomar Strategies Inc.###Session Leader: – TPIreg, a Division of Innomar Strategies Inc.
### @@@ Stefan Bolleininger (he/him/his) – be-on-Quality GmbH ### 2361490###Presenter###Consultant, Thinker, CEO###be-on-Quality GmbH###Presenter: – be-on-Quality GmbH
### he/him/his1:00 PM – 2:00 PM PDT
FDA Forecast: What the FDA has Planned in 2025 for Pharmaceuticals and Biotechnology Products
1:00 PM – 2:00 PM PDT
FDA Forecast: What the FDA has Planned in 2025 for Pharmaceuticals and Biotechnology ProductsPresenter: – AgencyIQ
Presenter: – Pink Sheet
Presenter: – PwC
Moderator: – Accumulus Synergy
Biopharmaceuticals (includes Biologics and Drugs)
Alexander Gaffney, MS, RAC (he/him/his) – AgencyIQ ### 1729641###Presenter###Executive Director, Regulatory Policy and Intelligence###AgencyIQ###Presenter: – AgencyIQ
### he/him/his @@@ Derrick J. Gingery (he/him/his) – Pink Sheet ### 2274990###Presenter###Executive Editor, Regulatory and Policy Insights, U.S.###Pink Sheet###Presenter: – Pink Sheet
### he/him/his @@@ Kelly Griffin, PhD, RAC – PwC ### 2274991###Presenter###Director, Regulatory Policy and Intelligence###PwC###Presenter: – PwC
### @@@ Ashley Jones-Mitchell, BS (she/her/hers) – Accumulus Synergy ### 2291809###Moderator###Director, Regulatory Innovation Strategy and Policy###Accumulus Synergy###Moderator: – Accumulus Synergy
### she/her/hers1:00 PM – 2:00 PM PDT
New FDA "Off-label" Information Guidance—Legal Implications and Practical Takeaways
1:00 PM – 2:00 PM PDT
New FDA "Off-label" Information Guidance—Legal Implications and Practical TakeawaysSession Leader: – Siemens Healthineers
Presenter: – BSI
Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)
Monika Bhatt (she/her/hers) – Siemens Healthineers ### 1614394###Session Leader###Chief FDA and Regulatory Healthcare Compliance Counsel###Siemens Healthineers###Session Leader: – Siemens Healthineers
### she/her/hers @@@ Richard G. Holborow (he/him/his) – BSI ### 1054191###Presenter###Global Head of Clinical Compliance###BSI###Presenter: – BSI
### he/him/his1:00 PM – 2:00 PM PDT
Regulatory Challenges in New Drug Approval in India and the Way Forward
1:00 PM – 2:00 PM PDT
Regulatory Challenges in New Drug Approval in India and the Way ForwardPresenter: – REGULATORY WISDOM
Moderator: – Genentech and Roche
Biopharmaceuticals (includes Biologics and Drugs)
Rashmi Kulshrestha, PhD (she/her/hers) – REGULATORY WISDOM ### 1614384###Presenter###FOUNDER & CEO###REGULATORY WISDOM###Presenter: – REGULATORY WISDOM
### she/her/hers @@@ Chin-Wei Soo, DRSc, FRAPS (he/him/his) – Genentech and Roche ### 1946101###Moderator###Global Regulatory Head, Devices and Combination Products###Genentech and Roche###Moderator: – Genentech and Roche
### he/him/his1:00 PM – 2:00 PM PDT
The importance of Data Standardization in Clinical Trials; an update from an MDIC supported project
1:00 PM – 2:00 PM PDT
The importance of Data Standardization in Clinical Trials; an update from an MDIC supported projectSession Leader: – Veeva Systems
Presenter: – MDIC
Presenter: – Roche
Presenter: – Roche Diagnostics
Devices (includes Medical Devices and In Vitro Diagnostics)
Amra Racic – Veeva Systems ### 535477###Session Leader###Sr. Director Global Government Affairs###Veeva Systems###Session Leader: – Veeva Systems
### @@@ Pipper White, MSc (she/her/hers) – MDIC ### 2275008###Presenter###Sr. Program Manager###MDIC###Presenter: – MDIC
### she/her/hers @@@ Nick Decker – Roche ### 2275009###Presenter###Head of Regulatory Policy - Global Standards & Postmarket###Roche###Presenter: – Roche
### @@@ Alyssa Nicholas, MS (she/her/hers) – Roche Diagnostics ### 2235912###Presenter###Senior Quality partner###Roche Diagnostics###Presenter: – Roche Diagnostics
### she/her/hers2:15 PM – 3:15 PM PDT
2024 LDT Regulatory Shifts: Understanding Impacts & Strategic Adaptation for Stakeholders
2:15 PM – 3:15 PM PDT
2024 LDT Regulatory Shifts: Understanding Impacts & Strategic Adaptation for StakeholdersPresenter: – Summit Therapeutics
Presenter: – Blackhawk Genomics
Presenter: – Siemens Healthineers
Devices (includes Medical Devices and In Vitro Diagnostics)
Aditi Khurana, RAC, PMP, CG, MB (she/her/hers) – Summit Therapeutics ### 1340362###Presenter###Director Project Management###Summit Therapeutics###Presenter: – Summit Therapeutics
### she/her/hers @@@ Cynthe Sims, PhD, HCLD(ABB) (she/her/hers) – Blackhawk Genomics ### 2275670###Presenter###Vice President of Clinical Diagnostics###Blackhawk Genomics###Presenter: – Blackhawk Genomics
### she/her/hers @@@ Monika Bhatt (she/her/hers) – Siemens Healthineers ### 1614394###Presenter###Chief FDA and Regulatory Healthcare Compliance Counsel###Siemens Healthineers###Presenter: – Siemens Healthineers
### she/her/hers2:15 PM – 3:15 PM PDT
Accelerating Novel Platforms into the Clinic: Early Experiences with FDA’s Advanced Manufacturing Technology (AMT) Designation
2:15 PM – 3:15 PM PDT
Accelerating Novel Platforms into the Clinic: Early Experiences with FDA’s Advanced Manufacturing Technology (AMT) DesignationPresenter: – Cytiva
Presenter: – Cytiva
Biopharmaceuticals (includes Biologics and Drugs)
Angela N. Johnson, PhD, RAC – Cytiva ### 535453###Presenter###Head of GloballRegulatory Compliance###Cytiva###Presenter: – Cytiva
### @@@ Melanie Sorensen (she/her/hers) – Cytiva ### 2275440###Presenter###Lead Regulatory Strategist###Cytiva###Presenter: – Cytiva
### she/her/hers2:15 PM – 3:15 PM PDT
Clinical Trials in Pregnancy and Lactation: Time for a Paradigm Shift?
2:15 PM – 3:15 PM PDT
Clinical Trials in Pregnancy and Lactation: Time for a Paradigm Shift?Session Leader: – UCB
Presenter: – University of North Carolina at Chapel Hill
Presenter: – FDA Center for Drug Evaluation and Research
Biopharmaceuticals (includes Biologics and Drugs)
Marie Teil, MD (she/her/hers) – UCB ### 1828299###Session Leader###Global Head of WoCBA###UCB###Session Leader: – UCB
### she/her/hers @@@ Anne Lyerly (she/her/hers) – University of North Carolina at Chapel Hill ### 2274998###Presenter###Professor###University of North Carolina at Chapel Hill###Presenter: – University of North Carolina at Chapel Hill
### she/her/hers @@@ Tamara Johnson, MD, MS (she/her/hers) – FDA Center for Drug Evaluation and Research ### 2364485###Presenter###Lead Physician###FDA Center for Drug Evaluation and Research###Presenter: – FDA Center for Drug Evaluation and Research
### she/her/hers2:15 PM – 3:15 PM PDT
Health Authority Forum: CDRH - FDA's Center for Devices and Radiological Health
2:15 PM – 3:15 PM PDT
Health Authority Forum: CDRH - FDA's Center for Devices and Radiological HealthHealth Authority Session
2:15 PM – 3:15 PM PDT
Monitoring AI Devices
2:15 PM – 3:15 PM PDT
Monitoring AI DevicesPresenter: – MDIC
Presenter: – Google
Presenter: – Medtronic
Devices (includes Medical Devices and In Vitro Diagnostics)
Jithesh Veetil, PhD (he/him/his) – MDIC ### 2275013###Presenter###Senior Director (Digital Health)###MDIC###Presenter: – MDIC
### he/him/his @@@ Jay Nayar, RAC – Google ### 2275014###Presenter###Regulatory Affairs Lead, Health AI###Google###Presenter: – Google
### @@@ Tealman Bjoraker – Medtronic ### 2275015###Presenter###Senior Regulatory Affairs Manager###Medtronic###Presenter: – Medtronic
### 2:15 PM – 3:15 PM PDT
Nurturing a Regulatory Excellence Ecosystem: Cultivating the Culture of Regulatory Affairs in Early Career Professionals
2:15 PM – 3:15 PM PDT
Nurturing a Regulatory Excellence Ecosystem: Cultivating the Culture of Regulatory Affairs in Early Career ProfessionalsPresenter: – Northeastern University
Presenter: – Veeva Systems
Presenter: – Alphatec Spine
Skill Building
Harshit R. Bhoraniya, MS (he/him/his) – Northeastern University ### 2275022###Presenter###Regulatory Affairs Graduate###Northeastern University###Presenter: – Northeastern University
### he/him/his @@@ Amra Racic – Veeva Systems ### 535477###Presenter###Sr. Director Global Government Affairs###Veeva Systems###Presenter: – Veeva Systems
### @@@ Griffin Riggs, MS (he/him/his) – Alphatec Spine ### 2381043###Presenter###Regulatory Affairs Associate###Alphatec Spine###Presenter: – Alphatec Spine
### he/him/his2:15 PM – 3:15 PM PDT
Quantifying Patient Burden in Protocol Design to Reduce Complexity and Drive Patient-Centricity
2:15 PM – 3:15 PM PDT
Quantifying Patient Burden in Protocol Design to Reduce Complexity and Drive Patient-CentricityPresenter: – PricewaterhouseCoopers (PwC)
Presenter: – FDA / CDER
Biopharmaceuticals (includes Biologics and Drugs)
Kathleen Sheridan, MS (she/her/hers) – PricewaterhouseCoopers (PwC) ### 2275439###Presenter###Manager###PricewaterhouseCoopers (PwC)###Presenter: – PricewaterhouseCoopers (PwC)
### she/her/hers @@@ Selena Daniels, PharmD, PhD (she/her/hers) – FDA / CDER ### 2403615###Presenter###Deputy Director, Division of Clinical Outcome Assessment###FDA / CDER###Presenter: – FDA / CDER
### she/her/hers2:15 PM – 3:15 PM PDT
UKCA & Market Developments
2:15 PM – 3:15 PM PDT
UKCA & Market DevelopmentsModerator: – Qserve Group
Presenter: – TUV SUD
Presenter: – BSI
Presenter: – MHRA
Presenter: – ABHI
Devices (includes Medical Devices and In Vitro Diagnostics)
Sue Spencer – Qserve Group ### 1187575###Moderator###Head IVD Business Unit and UK Country Manager###Qserve Group###Moderator: – Qserve Group
### @@@ Monisha Phillips, PhD (she/her/hers) – TUV SUD ### 2177812###Presenter###Head of Approved Body###TUV SUD###Presenter: – TUV SUD
### she/her/hers @@@ Vishal Thakker, MEng (he/him/his) – BSI ### 1614543###Presenter###Head of the UK Approved Body###BSI###Presenter: – BSI
### he/him/his @@@ Robert Reid – MHRA ### 2404505###Presenter###Deputy Director, Innovative Devices###MHRA###Presenter: – MHRA
### @@@ Stephen Lee – ABHI ### 1534229###Presenter###Director of Diagnostics & Digital Regulation###ABHI###Presenter: – ABHI
### 3:15 PM – 4:30 PM PDT
Presentations & Networking in Exhibit Hall
3:15 PM – 4:30 PM PDT
Presentations & Networking in Exhibit HallNetworking Opportunity
Exhibit Hall
3:15 PM – 4:30 PM PDT
Refreshment Break in the Exhibit Hall
3:15 PM – 4:30 PM PDT
Refreshment Break in the Exhibit HallExhibit Hall
3:30 PM – 3:55 PM PDT
Sponsored Presentation in the Discover Theater
3:30 PM – 3:55 PM PDT
Sponsored Presentation in the Discover Theater
3:30 PM – 3:55 PM PDT
Sponsored Presentation in the Ignite Theater
3:30 PM – 3:55 PM PDT
Sponsored Presentation in the Ignite Theater
3:30 PM – 3:55 PM PDT
Sponsored Presentation in the Spark Theater
3:30 PM – 3:55 PM PDT
Sponsored Presentation in the Spark Theater
4:00 PM – 4:25 PM PDT
Sponsored Presentation in the Discover Theater
4:00 PM – 4:25 PM PDT
Sponsored Presentation in the Discover Theater
4:00 PM – 4:25 PM PDT
Sponsored Presentation in the Ignite Theater
4:00 PM – 4:25 PM PDT
Sponsored Presentation in the Ignite Theater
4:00 PM – 4:25 PM PDT
Sponsored Presentation in the Spark Theater
4:00 PM – 4:25 PM PDT
Sponsored Presentation in the Spark Theater
4:00 PM – 4:30 PM PDT
AI's Transformative Impact on CMC in Pharmaceuticals
4:00 PM – 4:30 PM PDT
AI's Transformative Impact on CMC in PharmaceuticalsExhibit Hall: Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Anusha Saripalli – Neuron 23 ### 2275549###Facilitator###Scientist, CMC Formulations ###Neuron 23###Facilitator: – Neuron 23
### 4:00 PM – 4:30 PM PDT
Navigating the New Era of Regulatory Affairs: Technology as a Catalyst for Transformation
4:00 PM – 4:30 PM PDT
Navigating the New Era of Regulatory Affairs: Technology as a Catalyst for TransformationFacilitator: – Integrated Project Management
Exhibit Hall: Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Gregory L. Palagi (he/him/his) – Integrated Project Management ### 2043809###Facilitator###Senior Consult###Integrated Project Management###Facilitator: – Integrated Project Management
### he/him/his4:00 PM – 4:30 PM PDT
Working in the Grey: Clinical Decision Support Software vs. Software as a Medical Device
4:00 PM – 4:30 PM PDT
Working in the Grey: Clinical Decision Support Software vs. Software as a Medical DeviceExhibit Hall: Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Laura Szkolar-Sienkiewicz, PhD, PMP, RAC – Microsoft ### 2275616###Facilitator###Principal, Data Governance & Regulation###Microsoft###Facilitator: – Microsoft
### 4:30 PM – 5:30 PM PDT
Dive Deep: Navigating the Regulatory Maze of Concurrent regulatory submissions
4:30 PM – 5:30 PM PDT
Dive Deep: Navigating the Regulatory Maze of Concurrent regulatory submissionsModerator: – Integrated Project Management
Moderator: – Integrated Project Management
Panelist: – Entrada Therapeutics
Panelist: – Temple University
Panelist: – Novo Nordisk
Skill Building
Stacy Townsend, PhD, PMP, SSM – Integrated Project Management ### 1615693###Moderator###Director###Integrated Project Management###Moderator: – Integrated Project Management
### @@@ Vidya Narayanaswamy, MS, MBA, PMP, SSM (she/her/hers) – Integrated Project Management ### 2362194###Moderator###Consultant###Integrated Project Management###Moderator: – Integrated Project Management
### she/her/hers @@@ Celina Pettersen, MS – Entrada Therapeutics ### 2362195###Panelist###Associate Director, Regulatory Affairs###Entrada Therapeutics###Panelist: – Entrada Therapeutics
### @@@ Cassandra T. San Jose, MS (she/her/hers) – Temple University ### 2362196###Panelist###Regulatory Affairs###Temple University###Panelist: – Temple University
### she/her/hers @@@ Meriem Gaval Cruz, PhD, RAC (she/her/hers) – Novo Nordisk ### 2362197###Panelist###Director, Gobal Regulatory Lead###Novo Nordisk###Panelist: – Novo Nordisk
### she/her/hers4:30 PM – 5:30 PM PDT
Emerging Standard Developments in PFAS
4:30 PM – 5:30 PM PDT
Emerging Standard Developments in PFASSession Leader: – DEKRA Certification
Presenter: – TUV SUD Product Service
Presenter:
Devices (includes Medical Devices and In Vitro Diagnostics)
Catherine V. Moustakas (she/her/hers) – DEKRA Certification ### 2275672###Session Leader###Managing Director###DEKRA Certification###Session Leader: – DEKRA Certification
### she/her/hers @@@ Benedikt Hendan, PhD (he/him/his) – TUV SUD Product Service ### 2275674###Presenter###Team Leader, Technical Competence Center###TUV SUD Product Service ###Presenter: – TUV SUD Product Service
### he/him/his @@@ Lindsey Zocolo ### 2304780###Presenter#########Presenter:
### 4:30 PM – 5:30 PM PDT
Global Tools to Expedite Advanced Therapy Product Development
4:30 PM – 5:30 PM PDT
Global Tools to Expedite Advanced Therapy Product DevelopmentModerator: – IAA Consulting LLC
Presenter: – Agency IQ
Presenter: – US Food and Drug Administration
Biopharmaceuticals (includes Biologics and Drugs)
Linda McBride, R.Ph., RAC – IAA Consulting LLC ### 1946958###Moderator###Partner###IAA Consulting LLC###Moderator: – IAA Consulting LLC
### @@@ Kirsten Messmer, PhD, RAC – Agency IQ ### 595312###Presenter###Senior Research Analyst###Agency IQ###Presenter: – Agency IQ
### @@@ Jessica Boehmer, MBA (she/her/hers) – US Food and Drug Administration ### 1094840###Presenter###Associate Director for Regulatory Policy, CBER/OTP/ORMRR###US Food and Drug Administration###Presenter: – US Food and Drug Administration
### she/her/hers4:30 PM – 5:30 PM PDT
International Regulator Forum
4:30 PM – 5:30 PM PDT
International Regulator ForumHealth Authority Session
4:30 PM – 5:30 PM PDT
Live LinkedIn Feedback Session
4:30 PM – 5:30 PM PDT
Live LinkedIn Feedback Session
4:30 PM – 5:30 PM PDT
Real World Evidence in Device Applications: the 2024 update
4:30 PM – 5:30 PM PDT
Real World Evidence in Device Applications: the 2024 updatePresenter: – NDA Partners
Devices (includes Medical Devices and In Vitro Diagnostics)
Stephen C. Weber, Assistant Professor (he/him/his) – NDA Partners ### 1187557###Presenter###expert consultant###NDA Partners###Presenter: – NDA Partners
### he/him/his4:30 PM – 5:30 PM PDT
Regulatory Excellence: Japan's Type 1 Cartagena Process for Gene Therapy Products
4:30 PM – 5:30 PM PDT
Regulatory Excellence: Japan's Type 1 Cartagena Process for Gene Therapy ProductsSession Leader: – PPD, a part of Thermo Fisher Scientific
Presenter: – PPD-SNBL
Biopharmaceuticals (includes Biologics and Drugs)
Carla Gomes, PharmD, MBA – PPD, a part of Thermo Fisher Scientific ### 1827175###Session Leader###Senior Director, Regulatory Affairs###PPD, a part of Thermo Fisher Scientific###Session Leader: – PPD, a part of Thermo Fisher Scientific
### @@@ Machiko Goto, MS in agriculture (she/her/hers) – PPD-SNBL ### 2275012###Presenter###Regulatory Affairs Specialist###PPD-SNBL###Presenter: – PPD-SNBL
### she/her/hers4:30 PM – 5:30 PM PDT
What is New with Clinical Data Under the MDR? Interactive Panel Session with Notified Bodies
4:30 PM – 5:30 PM PDT
What is New with Clinical Data Under the MDR? Interactive Panel Session with Notified BodiesSession Leader: – Akra Team Inc.
Presenter: – BSI
Presenter: – TÜV Rheinland LGA Products GmbH
Presenter: – TÜV SÜD Product Service GmbH
Devices (includes Medical Devices and In Vitro Diagnostics)
Matthias Fink, MD – Akra Team Inc. ### 1945993###Session Leader###Senior Clinical Consultant###Akra Team Inc.###Session Leader: – Akra Team Inc.
### @@@ Richard G. Holborow (he/him/his) – BSI ### 1054191###Presenter###Global Head of Clinical Compliance###BSI###Presenter: – BSI
### he/him/his @@@ Christoph Ziskoven, MD (he/him/his) – TÜV Rheinland LGA Products GmbH ### 1945994###Presenter###Global Head of Technical Competence Center Medical Devices###TÜV Rheinland LGA Products GmbH###Presenter: – TÜV Rheinland LGA Products GmbH
### he/him/his @@@ Ulrich Nitsche, MD (he/him/his) – TÜV SÜD Product Service GmbH ### 1183856###Presenter###Head of Department Clinical Assessment###TÜV SÜD Product Service GmbH###Presenter: – TÜV SÜD Product Service GmbH
### he/him/his5:45 PM – 7:15 PM PDT
Honoring Excellence: RAPS 2024 Awards Celebration (Invitation Only)
5:45 PM – 7:15 PM PDT
Honoring Excellence: RAPS 2024 Awards Celebration (Invitation Only)Separate Ticketed Event
7:30 PM – 9:00 PM PDT
Dine Arounds (Sign-up Required)
7:30 PM – 9:00 PM PDT
Dine Arounds (Sign-up Required)Reservation Required
7:30 PM – 10:00 PM PDT
Networking Dinner Event (Ticketed Event)
7:30 PM – 10:00 PM PDT
Networking Dinner Event (Ticketed Event)Separate Ticketed Event
Networking Opportunity
- Thursday, September 19, 2024
6:30 AM – 4:30 PM PDT
Speaker Ready Room Hours
6:30 AM – 4:30 PM PDT
Speaker Ready Room Hours
7:00 AM – 8:00 AM PDT
Community Gathering & Continental Breakfast
7:00 AM – 8:00 AM PDT
Community Gathering & Continental Breakfast
7:00 AM – 4:00 PM PDT
Registration Hours
7:00 AM – 4:00 PM PDT
Registration Hours
7:00 AM – 6:30 PM PDT
First Aid Hours
7:00 AM – 6:30 PM PDT
First Aid Hours
8:00 AM – 9:00 AM PDT
RAPS Convergence 2024 Morning Plenary Session
8:00 AM – 9:00 AM PDT
RAPS Convergence 2024 Morning Plenary Session
9:15 AM – 10:30 AM PDT
China Drug Regulatory Pathways
9:15 AM – 10:30 AM PDT
China Drug Regulatory PathwaysSession Leader: – Cisema
Presenter: – PPD Inc
Presenter: – PPD Inc
Biopharmaceuticals (includes Biologics and Drugs)
Hamish King, RAC, LLB – Cisema ### 1321685###Session Leader###CEO###Cisema###Session Leader: – Cisema
### @@@ Vincent (Wenbo) Zhou – PPD Inc ### 2275679###Presenter###Associate Director, Regulatory Affairs###PPD Inc###Presenter: – PPD Inc
### @@@ Lisa Huang – PPD Inc ### 2275673###Presenter###Senior Manager Regulatory Affairs###PPD Inc###Presenter: – PPD Inc
### 9:15 AM – 10:30 AM PDT
Conversations That Matter - Interactions with Health Authorities: Medical Devices and IVDs
9:15 AM – 10:30 AM PDT
Conversations That Matter - Interactions with Health Authorities: Medical Devices and IVDsHealth Authority Session
9:15 AM – 10:30 AM PDT
Dangerous Documents: Avoiding Landmines in Your Records and Emails
9:15 AM – 10:30 AM PDT
Dangerous Documents: Avoiding Landmines in Your Records and EmailsSession Leader: – Compliance-Alliance, LLC
Presenter: – Wolters Kluwer UpToDate, Inc.
Presenter: – BD
Presenter: – Hologic Inc.
Skill Building
Nancy Singer, JD, LLM, RAC, FRAPS – Compliance-Alliance, LLC ### 862304###Session Leader###President###Compliance-Alliance, LLC###Session Leader: – Compliance-Alliance, LLC
### @@@ Susan Speicher, MS, RAC (she/her/hers) – Wolters Kluwer UpToDate, Inc. ### 1976561###Presenter###Director, Reglatory Affairs and Quality Compliance###Wolters Kluwer UpToDate, Inc.###Presenter: – Wolters Kluwer UpToDate, Inc.
### she/her/hers @@@ Sally Thorsen – BD ### 2342449###Presenter###Sr Director Regulatory Compliance and QMS###BD###Presenter: – BD
### @@@ Laura I. Ballesteros (she/her/hers) – Hologic Inc. ### 2342451###Presenter###Director Global QARA Compliance###Hologic Inc.###Presenter: – Hologic Inc.
### she/her/hers9:15 AM – 10:30 AM PDT
Empowering Brand Success: Fostering Dynamic Partnerships Between Regulatory and Marketing Teams
9:15 AM – 10:30 AM PDT
Empowering Brand Success: Fostering Dynamic Partnerships Between Regulatory and Marketing TeamsPresenter: – Klick Health
Presenter: – KLICK
Biopharmaceuticals (includes Biologics and Drugs)
Margot Arntfield, PhD – Klick Health ### 2275678###Presenter###Vice President, Science and Regulatory###Klick Health###Presenter: – Klick Health
### @@@ Jullie Turnbull – KLICK ### 2289918###Presenter######KLICK###Presenter: – KLICK
### 9:15 AM – 10:30 AM PDT
Initial Experience with Predetermined Change Control Plans and FDA’s PCCP Guidance / Principles
9:15 AM – 10:30 AM PDT
Initial Experience with Predetermined Change Control Plans and FDA’s PCCP Guidance / PrinciplesModerator: – Hogan Lovells LLP
Presenter: – Medtronic
Presenter: – Amazon
Presenter: – Epitel
Devices (includes Medical Devices and In Vitro Diagnostics)
Alex W. Smith, RAC – Hogan Lovells LLP ### 2275023###Moderator###Director of Regulatory Sciences###Hogan Lovells LLP###Moderator: – Hogan Lovells LLP
### @@@ Yarmela Pavlovic – Medtronic ### 2275005###Presenter###VP Global Regulatory Affairs, Strategy & Policy###Medtronic###Presenter: – Medtronic
### @@@ Shilpa Prem, J.D. – Amazon ### 2275006###Presenter###Product Counsel (Lawyer) in Health Tech###Amazon###Presenter: – Amazon
### @@@ Christopher Phillips, MSHS, RAC, CMDA – Epitel ### 2275004###Presenter###VP, Regulatory Affairs & Quality###Epitel###Presenter: – Epitel
### 9:15 AM – 10:30 AM PDT
Notified Body Forum: State of Play EU MDR and EU IVDR
9:15 AM – 10:30 AM PDT
Notified Body Forum: State of Play EU MDR and EU IVDRSession Leader: – AKRA TEAM
Presenter: – TÜV SÜD Medical Health Services
Presenter: – QServe Group B.V.
Presenter: – DNV Product Assurance AS
Presenter: – BSI
Presenter: – GMED
Panelist: – Scarlet
Devices (includes Medical Devices and In Vitro Diagnostics)
Bassil Akra (he/him/his) – AKRA TEAM ### 535482###Session Leader###CEO###AKRA TEAM###Session Leader: – AKRA TEAM
### he/him/his @@@ Sabina Hoekstra, PharmD FRAPS – TÜV SÜD Medical Health Services ### 1083897###Presenter###Global Director Regulatory Strategy###TÜV SÜD Medical Health Services###Presenter: – TÜV SÜD Medical Health Services
### @@@ Gert W. Bos, Chairman of the Board and former president RAPS – QServe Group B.V. ### 535440###Presenter###Executive Director & Partner###QServe Group B.V.###Presenter: – QServe Group B.V.
### @@@ Alexey Shiryaev, MD PhD – DNV Product Assurance AS ### 1645653###Presenter###Global Head of Clinical and Regulatory Affairs###DNV Product Assurance AS###Presenter: – DNV Product Assurance AS
### @@@ Suzanne Halliday – BSI ### 535446###Presenter###VP Regulatory###BSI###Presenter: – BSI
### @@@ Catherine Holzmann, PhD – GMED ### 1828311###Presenter###IVD Department Manager###GMED###Presenter: – GMED
### @@@ James Dewar (he/him/his) – Scarlet ### 2395106###Panelist###Head of Notified Body###Scarlet###Panelist: – Scarlet
### he/him/his9:15 AM – 10:30 AM PDT
Submission Strategies for Cybersecurity: Meeting the New Bar
9:15 AM – 10:30 AM PDT
Submission Strategies for Cybersecurity: Meeting the New BarSession Leader: – MedSec
Presenter: – Medtronic
Presenter: – BD
Presenter: – Bayer
Devices (includes Medical Devices and In Vitro Diagnostics)
Rene' Hardee (she/her/hers) – MedSec ### 2275024###Session Leader###Director of Regulatory Affairs and Program Management###MedSec###Session Leader: – MedSec
### she/her/hers @@@ Chris Reed (he/him/his) – Medtronic ### 2275018###Presenter###VP Product Security###Medtronic###Presenter: – Medtronic
### he/him/his @@@ Edison Alvarez – BD ### 2275019###Presenter###Sr. Dir. Regulatory Strategic Planning for Cybersecurity###BD###Presenter: – BD
### @@@ Chad Williams – Bayer ### 2275020###Presenter###Sr. Dir. Engineering###Bayer###Presenter: – Bayer
### 9:15 AM – 10:30 AM PDT
The European Pharmaceutical Legislation Revision – Status update and ongoing challenges
9:15 AM – 10:30 AM PDT
The European Pharmaceutical Legislation Revision – Status update and ongoing challengesSession Leader: – Agency IQ
Presenter: – IPSEN PHARMA
Biopharmaceuticals (includes Biologics and Drugs)
Kirsten Messmer, PhD, RAC – Agency IQ ### 595312###Session Leader###Senior Research Analyst###Agency IQ###Session Leader: – Agency IQ
### @@@ Martine Zimmermann, PharmD (she/her/hers) – IPSEN PHARMA ### 1452236###Presenter###SVP, Head of Global Regulatory Affairs###IPSEN PHARMA###Presenter: – IPSEN PHARMA
### she/her/hers10:30 AM – 1:00 PM PDT
Presentations & Networking in Exhibit Hall
10:30 AM – 1:00 PM PDT
Presentations & Networking in Exhibit HallNetworking Opportunity
Exhibit Hall
10:30 AM – 3:30 PM PDT
Exhibit Hall Hours
10:30 AM – 3:30 PM PDT
Exhibit Hall HoursExhibit Hall
10:35 AM – 11:05 AM PDT
How to Break Through the Regulatory Glass Ceiling and Get Hired!
10:35 AM – 11:05 AM PDT
How to Break Through the Regulatory Glass Ceiling and Get Hired!Facilitator: – Neuron23 Inc.
Exhibit Hall: Solutions Circle
Other
Yoshiko Stowell, PhD – Neuron23 Inc. ### 2274988###Facilitator###Head of Regulatory Affairs###Neuron23 Inc.###Facilitator: – Neuron23 Inc.
### 10:35 AM – 11:05 AM PDT
National Registrations and Other National Differences in the EU
10:35 AM – 11:05 AM PDT
National Registrations and Other National Differences in the EUExhibit Hall: Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Ludger J. Moeller (he/him/his) – MDSS GmbH ### 907125###Facilitator###President###MDSS GmbH###Facilitator: – MDSS GmbH
### he/him/his10:35 AM – 11:05 AM PDT
Submission of Implantable Medical Devices in Brazil: ANVISA's Class III and IV Requirements
10:35 AM – 11:05 AM PDT
Submission of Implantable Medical Devices in Brazil: ANVISA's Class III and IV RequirementsFacilitator: – Vera Rosas Group
Exhibit Hall: Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Patricia Luchiari Verrone (she/her/hers) – Vera Rosas Group ### 2275542###Facilitator###Regulatory Affairs Manager###Vera Rosas Group###Facilitator: – Vera Rosas Group
### she/her/hers10:35 AM – 11:05 AM PDT
The Impact of Regulatory Control Measures on Access to Opioid Analgesics used for Pain Management in Botswana
10:35 AM – 11:05 AM PDT
The Impact of Regulatory Control Measures on Access to Opioid Analgesics used for Pain Management in BotswanaFacilitator: – Botswana Medicines Regulatory Authority
Exhibit Hall: Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Tshetsana Senau (she/her/hers) – Botswana Medicines Regulatory Authority ### 2275543###Facilitator###Research Officer- Clinical Trials and Research###Botswana Medicines Regulatory Authority###Facilitator: – Botswana Medicines Regulatory Authority
### she/her/hers10:45 AM – 11:10 AM PDT
Sponsored Presentation in the Discover Theater
10:45 AM – 11:10 AM PDT
Sponsored Presentation in the Discover Theater
10:45 AM – 11:10 AM PDT
Sponsored Presentation in the Ignite Theater
10:45 AM – 11:10 AM PDT
Sponsored Presentation in the Ignite Theater
10:45 AM – 11:10 AM PDT
Sponsored Presentation in the Spark Theater
10:45 AM – 11:10 AM PDT
Sponsored Presentation in the Spark Theater
11:10 AM – 11:40 AM PDT
ADCs CMC – Regulatory Overreach or as Easy as ABC?
11:10 AM – 11:40 AM PDT
ADCs CMC – Regulatory Overreach or as Easy as ABC?Facilitator: – Parexel Regulatory Consulting
Exhibit Hall: Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Michael Craig, BSc Pharm MPSI – Parexel Regulatory Consulting ### 535462###Facilitator###Vice President (Technical)###Parexel Regulatory Consulting###Facilitator: – Parexel Regulatory Consulting
### 11:10 AM – 11:40 AM PDT
Diversity in Clinical Trials
11:10 AM – 11:40 AM PDT
Diversity in Clinical TrialsFacilitator: – Lexicon Pharmaceuticals Inc.
Exhibit Hall: Solutions Circle
Other
Anagha Shende, MBBS, MD (she/her/hers) – Lexicon Pharmaceuticals Inc. ### 2275547###Facilitator###Medical Science &Outcomes Liaison###Lexicon Pharmaceuticals Inc.###Facilitator: – Lexicon Pharmaceuticals Inc.
### she/her/hers11:10 AM – 11:40 AM PDT
Health Authority Audit and Inspection 101: Best Practices for Research Organizations
11:10 AM – 11:40 AM PDT
Health Authority Audit and Inspection 101: Best Practices for Research OrganizationsFacilitator: – Integrated Project Management
Exhibit Hall: Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Olivia A. Seale, PMP, MBA, MS Pharmacology (she/her/hers) – Integrated Project Management ### 2275538###Facilitator###Consultant###Integrated Project Management###Facilitator: – Integrated Project Management
### she/her/hers11:10 AM – 11:40 AM PDT
PCCP - Predetermined Change Control Plan - Strategy with Case Studies for Medical Devices
11:10 AM – 11:40 AM PDT
PCCP - Predetermined Change Control Plan - Strategy with Case Studies for Medical DevicesFacilitator: – Siemens Healthineers
Exhibit Hall: Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Abhineet Johri – Siemens Healthineers ### 1828304###Facilitator###Senior Key expert AI and Regulatory affairs Manager###Siemens Healthineers###Facilitator: – Siemens Healthineers
### 11:15 AM – 11:50 AM PDT
Sponsored Presentation in the Discover Theater
11:15 AM – 11:50 AM PDT
Sponsored Presentation in the Discover Theater
11:15 AM – 11:50 AM PDT
Sponsored Presentation in the Ignite Theater
11:15 AM – 11:50 AM PDT
Sponsored Presentation in the Ignite Theater
11:15 AM – 11:50 AM PDT
Sponsored Presentation in the Spark Theater
11:15 AM – 11:50 AM PDT
Sponsored Presentation in the Spark Theater
11:30 AM – 1:00 PM PDT
Networking Lunch in the Exhibit Hall
11:30 AM – 1:00 PM PDT
Networking Lunch in the Exhibit HallNetworking Opportunity
Exhibit Hall
11:45 AM – 12:15 PM PDT
China Drug Master Files: Latest Points to Know for Pharma Manufacturers
11:45 AM – 12:15 PM PDT
China Drug Master Files: Latest Points to Know for Pharma ManufacturersExhibit Hall: Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Hamish King, RAC, LLB – Cisema ### 1321685###Facilitator###CEO###Cisema###Facilitator: – Cisema
### 11:45 AM – 12:15 PM PDT
Emerging Standard Developments in PFAS (Solution Circle)
11:45 AM – 12:15 PM PDT
Emerging Standard Developments in PFAS (Solution Circle)Facilitator: – DEKRA Certification
Devices (includes Medical Devices and In Vitro Diagnostics)
Catherine V. Moustakas (she/her/hers) – DEKRA Certification ### 2275672###Facilitator###Managing Director###DEKRA Certification###Facilitator: – DEKRA Certification
### she/her/hers11:45 AM – 12:15 PM PDT
Transformative Trends: Navigating the Evolving Regulatory Path for Laboratory Developed Tests
11:45 AM – 12:15 PM PDT
Transformative Trends: Navigating the Evolving Regulatory Path for Laboratory Developed TestsExhibit Hall: Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Megha Sinha ### 2344878###Facilitator#########Facilitator:
### 11:55 AM – 12:20 PM PDT
Sponsored Presentation in the Discover Theater
11:55 AM – 12:20 PM PDT
Sponsored Presentation in the Discover Theater
11:55 AM – 12:20 PM PDT
Sponsored Presentation in the Ignite Theater
11:55 AM – 12:20 PM PDT
Sponsored Presentation in the Ignite Theater
11:55 AM – 12:20 PM PDT
Sponsored Presentation in the Spark Theater
11:55 AM – 12:20 PM PDT
Sponsored Presentation in the Spark Theater
12:20 PM – 12:50 PM PDT
Charting the Course: Interactive Breakout Session on Navigating FDA Communication
12:20 PM – 12:50 PM PDT
Charting the Course: Interactive Breakout Session on Navigating FDA CommunicationFacilitator: – Eximis Surgical
Exhibit Hall: Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Hilary A. Baldwin – Eximis Surgical ### 2275534###Facilitator###Vice President of Regulatory, Quality, and Clinical Affairs###Eximis Surgical###Facilitator: – Eximis Surgical
### 12:20 PM – 12:50 PM PDT
Sponsored Presentation in the Ignite Theater
12:25 PM – 12:50 PM PDT
Sponsored Presentation in the Ignite Theater
12:20 PM – 12:50 PM PDT
USP’s Nitrosamines Exchange: Accelerating Pharmaceutical Quality Strategies
12:20 PM – 12:50 PM PDT
USP’s Nitrosamines Exchange: Accelerating Pharmaceutical Quality StrategiesFacilitator: – U.S. Pharmacopeia
Exhibit Hall: Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Naiffer Romero, MSc MPH (he/him/his) – U.S. Pharmacopeia ### 2275545###Facilitator###Principal Scientist • USP Global Science###U.S. Pharmacopeia###Facilitator: – U.S. Pharmacopeia
### he/him/his12:25 PM – 12:50 PM PDT
Sponsored Presentation in the Discover Theater
12:25 PM – 12:50 PM PDT
Sponsored Presentation in the Discover Theater
12:25 PM – 12:50 PM PDT
Sponsored Presentation in the Spark Theater
12:25 PM – 12:50 PM PDT
Sponsored Presentation in the Spark Theater
1:00 PM – 2:00 PM PDT
Best Practices for 510(k) Submissions Utilizing eSTAR
1:00 PM – 2:00 PM PDT
Best Practices for 510(k) Submissions Utilizing eSTARSession Leader: – Align Technology
Presenter: – Statera Regulatory Consulting
Presenter: – Regulatory Technology Services (RTS)
Devices (includes Medical Devices and In Vitro Diagnostics)
Surina Gulati, MBEE (she/her/hers) – Align Technology ### 2275688###Session Leader###Senior Quality Systems & Compliance Engineer###Align Technology###Session Leader: – Align Technology
### she/her/hers @@@ Melissa A. Hall, MS BME (she/her/hers) – Statera Regulatory Consulting ### 2215389###Presenter###Principal Consultant and Founder###Statera Regulatory Consulting###Presenter: – Statera Regulatory Consulting
### she/her/hers @@@ Prithul Bom, MS, MBA, RAC (US, EU) (she/her/hers) – Regulatory Technology Services (RTS) ### 2275682###Presenter###CEO, Regulatory Technology Services (RTS) 3P510(k) Review Organization###Regulatory Technology Services (RTS)###Presenter: – Regulatory Technology Services (RTS)
### she/her/hers1:00 PM – 2:00 PM PDT
Controlling Pharmaceutical Impurities: A Regulatory Perspective
1:00 PM – 2:00 PM PDT
Controlling Pharmaceutical Impurities: A Regulatory PerspectivePresenter: – Hogan Lovells LLP
Presenter: – Paraxel
Biopharmaceuticals (includes Biologics and Drugs)
Alex W. Smith, RAC – Hogan Lovells LLP ### 2275023###Presenter###Director of Regulatory Sciences###Hogan Lovells LLP###Presenter: – Hogan Lovells LLP
### @@@ Chris T. Middendorf (he/him/his) – Paraxel ### 2275017###Presenter###VP, Technical – Strategic Compliance Consulting###Paraxel###Presenter: – Paraxel
### he/him/his1:00 PM – 2:00 PM PDT
FDA Efforts to Promote Innovative Medical Product Development
1:00 PM – 2:00 PM PDT
FDA Efforts to Promote Innovative Medical Product DevelopmentModerator: – FDA
Presenter (Remote):
Presenter: – FDA/CBER/OTP
Presenter: – Office of Program Operations, Office of New Drugs, CDER, FDA
Presenter: – FDA
Biopharmaceuticals (includes Biologics and Drugs)
Ryan Presto – FDA ### 2344654###Moderator###Regulatory Officer###FDA###Moderator: – FDA
### @@@ Ingrid Markovic ### 2344655###Presenter (Remote)#########Presenter (Remote):
### @@@ Wei Liang (she/her/hers) – FDA/CBER/OTP ### 2055800###Presenter###Regulatory Operations Staff Chief###FDA/CBER/OTP###Presenter: – FDA/CBER/OTP
### she/her/hers @@@ Cathryn Lee, MSN CRNP (she/her/hers) – Office of Program Operations, Office of New Drugs, CDER, FDA ### 2364610###Presenter###Staff Director###Office of Program Operations, Office of New Drugs, CDER, FDA###Presenter: – Office of Program Operations, Office of New Drugs, CDER, FDA
### she/her/hers @@@ Kevin B. Bugin, PhD, MS, RAC (US) – FDA ### 2063738###Presenter###Deputy Director###FDA###Presenter: – FDA
### 1:00 PM – 2:00 PM PDT
Finding a Job in Regulatory Affairs or Regulatory Compliance: Skills for Success
1:00 PM – 2:00 PM PDT
Finding a Job in Regulatory Affairs or Regulatory Compliance: Skills for SuccessSession Leader: – UCSC Silicon Valley Extension
Presenter: – RefleXion Medical
Presenter: – Greenleaf Health
Presenter (Remote): – CDRH, Food and Drug Administration
Skill Building
Kiran Gulati, MBA, Exemplar Lead Auditor – UCSC Silicon Valley Extension ### 2275000###Session Leader###Program Chair-Regulatory Affairs and Medical Device Quality & Design###UCSC Silicon Valley Extension###Session Leader: – UCSC Silicon Valley Extension
### @@@ Jay Vaishnav, PhD, RAC-Devices (she/her/hers) – RefleXion Medical ### 2274993###Presenter###Director of Regulatory Affairs###RefleXion Medical###Presenter: – RefleXion Medical
### she/her/hers @@@ Kristen Grumet – Greenleaf Health ### 2274996###Presenter###Senior Vice President, Regulatory Compliance###Greenleaf Health###Presenter: – Greenleaf Health
### @@@ Catherine A. Olguin, PhD (she/her/hers) – CDRH, Food and Drug Administration ### 2274995###Presenter (Remote)###General Engineer - Imaging Software Team###CDRH, Food and Drug Administration###Presenter (Remote): – CDRH, Food and Drug Administration
### she/her/hers1:00 PM – 2:00 PM PDT
Regulatory Convergence of Biologics; APEC, ICH, WHO Efforts for LATAM and Around the World
1:00 PM – 2:00 PM PDT
Regulatory Convergence of Biologics; APEC, ICH, WHO Efforts for LATAM and Around the WorldSession Leader: – Northeastern University
Presenter: – Harvard Medical School
Presenter: – US Food and Drug Administration
Presenter: – US Food and Drug Administration
Biopharmaceuticals (includes Biologics and Drugs)
Jared Auclair, PhD – Northeastern University ### 2274989###Session Leader###Dean###Northeastern University###Session Leader: – Northeastern University
### @@@ Barbara E. Bierer, MD – Harvard Medical School ### 2275003###Presenter###Professor and Director###Harvard Medical School###Presenter: – Harvard Medical School
### @@@ Michelle Limoli, PharmD – US Food and Drug Administration ### 2275001###Presenter###International Affairs###US Food and Drug Administration###Presenter: – US Food and Drug Administration
### @@@ Judith Arcidiacono, MS (she/her/hers) – US Food and Drug Administration ### 2275002###Presenter###Advanced Therapies Regulatory Expert###US Food and Drug Administration###Presenter: – US Food and Drug Administration
### she/her/hers1:00 PM – 2:00 PM PDT
Start Ups | Unlocking Success in MedTech Innovation: Navigating Regulatory Challenges for Startups and Spin-Offs
1:00 PM – 2:00 PM PDT
Start Ups | Unlocking Success in MedTech Innovation: Navigating Regulatory Challenges for Startups and Spin-OffsPresenter: – Qserve
Presenter: – Akra Team Inc.
Presenter: – Indigo
Devices (includes Medical Devices and In Vitro Diagnostics)
Robert Paassen, MSc (he/him/his) – Qserve ### 2177852###Presenter###Consultant###Qserve###Presenter: – Qserve
### he/him/his @@@ Matthias Fink, MD – Akra Team Inc. ### 1945993###Presenter###Senior Clinical Consultant###Akra Team Inc.###Presenter: – Akra Team Inc.
### @@@ Rene Pot, MSc – Indigo ### 2275689###Presenter###Senior QA/RA Manager###Indigo###Presenter: – Indigo
### 1:00 PM – 2:00 PM PDT
Structured Dialogue for (IVD) Medical Devices in Europe: Now will finally get some answers (?)
1:00 PM – 2:00 PM PDT
Structured Dialogue for (IVD) Medical Devices in Europe: Now will finally get some answers (?)Presenter: – BSI
Presenter: – TÜV SÜD Medical Health Services
Presenter: – TüV Rheinland
Devices (includes Medical Devices and In Vitro Diagnostics)
Alex Laan (he/him/his) – BSI ### 1945990###Presenter###Head of IVD Notified Body###BSI###Presenter: – BSI
### he/him/his @@@ Sabina Hoekstra, PharmD FRAPS – TÜV SÜD Medical Health Services ### 1083897###Presenter###Global Director Regulatory Strategy###TÜV SÜD Medical Health Services###Presenter: – TÜV SÜD Medical Health Services
### @@@ Volker Schluter – TüV Rheinland ### 2374472###Presenter######TüV Rheinland###Presenter: – TüV Rheinland
### 2:00 PM – 3:15 PM PDT
Presentations & Networking in Exhibit Hall
2:00 PM – 3:15 PM PDT
Presentations & Networking in Exhibit HallNetworking Opportunity
Exhibit Hall
2:00 PM – 3:15 PM PDT
Refreshment Break in the Exhibit Hall
2:00 PM – 3:15 PM PDT
Refreshment Break in the Exhibit HallExhibit Hall
2:15 PM – 2:40 PM PDT
Sponsored Presentation in the Discover Theater
2:15 PM – 2:40 PM PDT
Sponsored Presentation in the Discover Theater
2:15 PM – 2:40 PM PDT
Sponsored Presentation in the Ignite Theater
2:15 PM – 2:40 PM PDT
Sponsored Presentation in the Ignite Theater
2:15 PM – 2:40 PM PDT
Sponsored Presentation in the Spark Theater
2:15 PM – 2:40 PM PDT
Sponsored Presentation in the Spark Theater
2:15 PM – 2:40 PM PDT
Sponsored Presentation in the Spark Theater
2:30 PM – 3:00 PM PDT
Navigating Regulatory Pathways: When to Submit a Special 510(k) vs. Internal Letter-to-File for Device Changes
2:30 PM – 3:00 PM PDT
Navigating Regulatory Pathways: When to Submit a Special 510(k) vs. Internal Letter-to-File for Device ChangesFacilitator: – MediView XR, Inc.
Exhibit Hall: Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Crew J. Weunski, M.S., RAC-Devices (he/him/his) – MediView XR, Inc. ### 1632165###Facilitator###Regulatory Affairs Lead###MediView XR, Inc.###Facilitator: – MediView XR, Inc.
### he/him/his2:45 PM – 3:10 PM PDT
Sponsored Presentation in the Discover Theater
2:45 PM – 3:10 PM PDT
Sponsored Presentation in the Discover Theater
2:45 PM – 3:10 PM PDT
Sponsored Presentation in the Ignite Theater
2:45 PM – 3:10 PM PDT
Sponsored Presentation in the Ignite Theater
3:15 PM – 4:15 PM PDT
Artificial Intelligence - Considerations for CE Marking for Medical Devices and IVDs
3:15 PM – 4:15 PM PDT
Artificial Intelligence - Considerations for CE Marking for Medical Devices and IVDsModerator: – Thermo Fisher Scientific
Session Leader: – Elekta
Presenter: – BSI
Presenter:
Devices (includes Medical Devices and In Vitro Diagnostics)
Francis Dekker, PhD (she/her/hers) – Thermo Fisher Scientific ### 1947568###Moderator###Senior Regulatory Affairs Manager###Thermo Fisher Scientific###Moderator: – Thermo Fisher Scientific
### she/her/hers @@@ Leo Hovestadt (he/him/his) – Elekta ### 535504###Session Leader###Director Governmental Affairs EU###Elekta###Session Leader: – Elekta
### he/him/his @@@ Sarah Mathew – BSI ### 2177832###Presenter###Regulatory Lead###BSI###Presenter: – BSI
### @@@ Sebastian Fischer ### 2385312###Presenter#########Presenter:
### 3:15 PM – 4:15 PM PDT
Expanding Global Access to Complex Generics: Comparative Study Unveils the Benefits of Regulatory Convergence
3:15 PM – 4:15 PM PDT
Expanding Global Access to Complex Generics: Comparative Study Unveils the Benefits of Regulatory ConvergencePresenter: – United States Pharmacopeia
Presenter: – United States Pharmacopeia
Presenter: – FDA/CDER/OGD
Biopharmaceuticals (includes Biologics and Drugs)
Victor S. Pribluda, PhD (he/him/his) – United States Pharmacopeia ### 1946097###Presenter###Senior International Regulatory Intelligence Manager###United States Pharmacopeia###Presenter: – United States Pharmacopeia
### he/him/his @@@ Chaitanya K. Koduri (he/him/his) – United States Pharmacopeia ### 1946105###Presenter###International Government & Regulatory Director###United States Pharmacopeia###Presenter: – United States Pharmacopeia
### he/him/his @@@ Sarah Ibrahim – FDA/CDER/OGD ### 2364557###Presenter###Associate Office Director###FDA/CDER/OGD###Presenter: – FDA/CDER/OGD
### 3:15 PM – 4:15 PM PDT
Health Authority Forum: CDER - FDA's Center for Drug Evaluation and Research
3:15 PM – 4:15 PM PDT
Health Authority Forum: CDER - FDA's Center for Drug Evaluation and ResearchHealth Authority Session
3:15 PM – 4:15 PM PDT
Impact of Public-Private Partnerships in Regulatory Science, Drug Development and Regulatory Decision-Making
3:15 PM – 4:15 PM PDT
Impact of Public-Private Partnerships in Regulatory Science, Drug Development and Regulatory Decision-MakingPresenter: – Critical Path Institute
Presenter: – FDA / CDER
Biopharmaceuticals (includes Biologics and Drugs)
Huong Huynh, PhD – Critical Path Institute ### 1779249###Presenter###Director of Regulatory Science###Critical Path Institute###Presenter: – Critical Path Institute
### @@@ Selena Daniels, PharmD, PhD (she/her/hers) – FDA / CDER ### 2403615###Presenter###Deputy Director, Division of Clinical Outcome Assessment###FDA / CDER###Presenter: – FDA / CDER
### she/her/hers3:15 PM – 4:15 PM PDT
Lessons learned since the implementation of FDA’s Diversity Plans & an assessment of the 2024 Diversity Action Plans FDA guidance
3:15 PM – 4:15 PM PDT
Lessons learned since the implementation of FDA’s Diversity Plans & an assessment of the 2024 Diversity Action Plans FDA guidanceModerator: – BioMarin Pharmaceuticals, Inc.
Presenter: – PhRMA
Biopharmaceuticals (includes Biologics and Drugs)
Jewell Martin, MA, MBA, PMP, RAC (she/her/hers) – BioMarin Pharmaceuticals, Inc. ### 1946971###Moderator###Director for US Regulatory Policy###BioMarin Pharmaceuticals, Inc.###Moderator: – BioMarin Pharmaceuticals, Inc.
### she/her/hers @@@ Mary Nwokedi, PharmD – PhRMA ### 2078161###Presenter###Director of Diversity in Clinical Trials ###PhRMA ###Presenter: – PhRMA
### 3:15 PM – 4:15 PM PDT
Precision Medicine using Companion Diagnostics, AI/ML modeling, and Digital Health Technology? Buzzwords or Reality?
3:15 PM – 4:15 PM PDT
Precision Medicine using Companion Diagnostics, AI/ML modeling, and Digital Health Technology? Buzzwords or Reality?Presenter: – Neuron23 Inc.
Presenter: – APS Pharma Solutions
Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)
Yoshiko Stowell, PhD – Neuron23 Inc. ### 2274988###Presenter###Head of Regulatory Affairs###Neuron23 Inc.###Presenter: – Neuron23 Inc.
### @@@ Kamana Singh, DVM, MVSc, MBA, RAC (she/her/hers) – APS Pharma Solutions ### 1615685###Presenter###Executive Consultant###APS Pharma Solutions###Presenter: – APS Pharma Solutions
### she/her/hers3:15 PM – 4:15 PM PDT
Updates in Pediatric Medical Device Development project SHIP-MD: New FNIH leadership vision
3:15 PM – 4:15 PM PDT
Updates in Pediatric Medical Device Development project SHIP-MD: New FNIH leadership visionSession Leader: – Veeva Systems
Presenter: – QServe Group B.V.
Devices (includes Medical Devices and In Vitro Diagnostics)
Amra Racic – Veeva Systems ### 535477###Session Leader###Sr. Director Global Government Affairs###Veeva Systems###Session Leader: – Veeva Systems
### @@@ Gert W. Bos, Chairman of the Board and former president RAPS – QServe Group B.V. ### 535440###Presenter###Executive Director & Partner###QServe Group B.V.###Presenter: – QServe Group B.V.
### 3:15 PM – 4:15 PM PDT
Using Foreign Data to and from China
3:15 PM – 4:15 PM PDT
Using Foreign Data to and from ChinaPresenter: – China Med Device, LLC
Presenter: – MD-CLINICALS SA
Presenter: – Whitney Consulting Ltd.
Moderator: – Takeda
Devices (includes Medical Devices and In Vitro Diagnostics)
Grace Fu Palma, MBA (she/her/hers) – China Med Device, LLC ### 1187560###Presenter###Principal###China Med Device, LLC###Presenter: – China Med Device, LLC
### she/her/hers @@@ Danielle Giroud, MSci, MBA (she/her/hers) – MD-CLINICALS SA ### 1187621###Presenter###Founder and CEO###MD-CLINICALS SA###Presenter: – MD-CLINICALS SA
### she/her/hers @@@ Chang-Hong Whitney, MBA RAC – Whitney Consulting Ltd. ### 1294674###Presenter###president/CEO###Whitney Consulting Ltd.###Presenter: – Whitney Consulting Ltd.
### @@@ Niedre M. Heckman, PhD, MPH, FRAPS, RAC, CQA (she/her/hers) – Takeda ### 1976559###Moderator###Director, Global Regulatory Affairs###Takeda###Moderator: – Takeda
### she/her/hers4:30 PM – 5:30 PM PDT
A Path to Faster Breakthrough Device Commercialization - CDRH's Total Product Life Cycle Advisory Program (TAP)
4:30 PM – 5:30 PM PDT
A Path to Faster Breakthrough Device Commercialization - CDRH's Total Product Life Cycle Advisory Program (TAP)Session Leader: – Hyman, Phelps & McNamara, P.C.
Presenter: – FDA
Devices (includes Medical Devices and In Vitro Diagnostics)
Adrienne Lenz, RAC – Hyman, Phelps & McNamara, P.C. ### 535486###Session Leader###Principal Medical Device Regulatory Expert###Hyman, Phelps & McNamara, P.C.###Session Leader: – Hyman, Phelps & McNamara, P.C.
### @@@ Laura Gottschalk, PhD (she/her/hers) – FDA ### 2392483###Presenter###TAP Advisor###FDA###Presenter: – FDA
### she/her/hers4:30 PM – 5:30 PM PDT
Addressing Menopause: From Unspoken Reality to Innovation Battlefield
4:30 PM – 5:30 PM PDT
Addressing Menopause: From Unspoken Reality to Innovation BattlefieldPresenter: – confinis
Presenter: – Private Praxis Anna Margareta Wagner
Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)
Andrea Biasiucci, PhD – confinis ### 1395023###Presenter###CEO###confinis###Presenter: – confinis
### @@@ Annalisa Rizzo – Private Praxis Anna Margareta Wagner ### 2275011###Presenter###Medical Doctor (Obstetrics & Gynecology)###Private Praxis Anna Margareta Wagner###Presenter: – Private Praxis Anna Margareta Wagner
### 4:30 PM – 5:30 PM PDT
Advancing Gene Therapy: A Holistic Approach to Multicomponent Product Development and Delivery Device Lifecycle
4:30 PM – 5:30 PM PDT
Advancing Gene Therapy: A Holistic Approach to Multicomponent Product Development and Delivery Device LifecycleSession Leader: – TPIreg, Innomar Strategies Inc
Presenter: – Health Cananda
Presenter:
Biopharmaceuticals (includes Biologics and Drugs)
Mary Speagle – TPIreg, Innomar Strategies Inc ### 2408934###Session Leader###Senior Director Regulatory and Scientific Affairs###TPIreg, Innomar Strategies Inc###Session Leader: – TPIreg, Innomar Strategies Inc
### @@@ Martin Nemec – Health Cananda ### 2370823###Presenter###Senior Biologist/Evaluator###Health Cananda###Presenter: – Health Cananda
### @@@ Alyssa Kitchel ### 2370824###Presenter#########Presenter:
### 4:30 PM – 5:30 PM PDT
Considerations for Global Harmonization and Accelerated Drug Development
4:30 PM – 5:30 PM PDT
Considerations for Global Harmonization and Accelerated Drug DevelopmentPresenter: – Gilead Sciences
Presenter: – US FDA
Biopharmaceuticals (includes Biologics and Drugs)
Sue Liu, B.Eng (pharm) MBA RAC – Gilead Sciences ### 2275671###Presenter###Executive Director, Quality###Gilead Sciences###Presenter: – Gilead Sciences
### @@@ Christopher Joneckis, PhD (he/him/his) – US FDA ### 601550###Presenter###Associate Director For Review Management/ Director Office of regulatory Operations, CBER###US FDA###Presenter: – US FDA
### he/him/his4:30 PM – 5:30 PM PDT
Health Authority Forum: CBER - FDA’s Center for Biologics Evaluation and Research (CBER)
4:30 PM – 5:30 PM PDT
Health Authority Forum: CBER - FDA’s Center for Biologics Evaluation and Research (CBER) Health Authority Session
4:30 PM – 5:30 PM PDT
Human Factors in Drug-Led Combination Products: Key Insights from Recent FDA Feedback on Validation Protocols
4:30 PM – 5:30 PM PDT
Human Factors in Drug-Led Combination Products: Key Insights from Recent FDA Feedback on Validation ProtocolsSession Leader: – Genentech
Presenter:
Biopharmaceuticals (includes Biologics and Drugs)
Nishchay Gupta – Genentech ### 2274992###Session Leader###Senior Regulatory Program Director###Genentech###Session Leader: – Genentech
### @@@ Sherri Biondi ### 2341884###Presenter#########Presenter:
### 4:30 PM – 5:30 PM PDT
Manufacturer's Approach to Advancing Health Equity for Medical Devices
4:30 PM – 5:30 PM PDT
Manufacturer's Approach to Advancing Health Equity for Medical DevicesDevices (includes Medical Devices and In Vitro Diagnostics)
4:30 PM – 5:30 PM PDT
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
4:30 PM – 5:30 PM PDT
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical DevicesSession Leader: – Mid-Link Group
Devices (includes Medical Devices and In Vitro Diagnostics)
William M. Sutton (he/him/his) – Mid-Link Group ### 2274994###Session Leader###VP North America###Mid-Link Group###Session Leader: – Mid-Link Group
### he/him/his6:00 PM – 9:00 PM PDT
RAPS Convergence 2024 Farewell Celebration
6:00 PM – 9:00 PM PDT
RAPS Convergence 2024 Farewell CelebrationNetworking Opportunity
