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Biopharmaceuticals (includes Biologics and Drugs)

Monday, Sep 16th

8:30 AM – 4:00 PM PDT

Drug Development in the EU: Regulatory Standards, Supports, and New Approaches

Location/Room: 104 A

Workshop Leader: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency

Presenter: Karl-Heinz Huemer – khhconsulting

Presenter: Sue Liu, B.Eng (pharm) MBA RAC – Gilead Sciences

Presenter: Daniela Drago, RAC, FRAPS – NDA Partners

Presenter: Sabine Haubenreisser, MSc, PhD – European Medicines Agency

Presenter: John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority

Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)

Tuesday, Sep 17th

8:30 AM – 4:00 PM PDT

Maximizing Opportunities to Engage With the FDA

Location/Room: 104 A

Workshop Leader: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceutical, Inc.

Workshop Leader: 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

Presenter: Angela W. Corona, PhD – BOLDAPPROVALS

Presenter: Christy Cottrell – FDA/CDER

Presenter: Ramani Sista, PhD – ORMRR/OTP/CBER/FDA

Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

9:15 AM – 10:30 AM PDT

Addressing Medicines Shortages in EU: Prevent, Mitigate, and Ensure Visibility

Location/Room: 202

Presenter: Romain Kherrat, PharmD – Clarivate

Presenter (Remote): Monica Dias, PhD – EMA

Presenter (Remote): Sofia Zastavnik – European Medicines Agency

Biopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

9:15 AM – 10:30 AM PDT

Increasing Consumer/Patient Access, Engagement and Health Equity: Innovation Leveraging FDA Proposed/New ACNU NDA Regulatory Pathway

Location/Room: 201

Session Leader: Paul A. Wardle, MA, MMath – Klick Health

Presenter: Erin Oliver, MS, MBA, FRAPS – Haleon

Presenter: Elisabeth Walther, PharmD, JD – FDA

Presenter: Danielle Terrell, PharmD, JD, MS, RAC-US – FDA

Biopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

9:15 AM – 10:30 AM PDT

Using Innovative Regulatory Strategies to Streamline Drug Development – Platform Trials, Model Informed Drug Development, and Real World Evidence

Location/Room: 203

Session Leader: Michelle Pernice, Pharm.D. – Fairmount Funds Management

Presenter: Chelsea O’Connell, MS, RAC – Amgen

Presenter (Remote): Laura Pioppo – EMA

Presenter (Remote): Rajanikanth Madabushi – FDA / CDER / OTS / OCP

Biopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

10:35 AM – 11:05 AM PDT

Solution Circle (D): Maximizing the Potential of Meetings with the FDA

Proficiency: Foundational/ Operational/ Novice

Location/Room: Exhibit Hall: Solutions Circles Area (D)

Facilitator: Hagit Marchaim, PhD – HMC-regulation; Dr. Hagit Marchaim RA and Drug Development Consulting

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

11:10 AM – 11:40 AM PDT

Solution Circle (C): The Right Balance Between Business, Science, and Regulation in Managing Supply Chains

Location/Room: Exhibit Hall: Solutions Circles Area (C)

Facilitator: Lopa Bakrania, PhD, RAC – Biohaven Pharmaceuticals

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

11:45 AM – 12:15 PM PDT

Solution Circle (C): Phase and Product Appropriate Regulatory Strategies in Impurity Characterizations and Controls

Location/Room: Exhibit Hall: Solutions Circles Area (C)

Facilitator: Hai Wang, PhD – El Vista Consulting LLC

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

12:20 PM – 12:50 PM PDT

Solution Circle (B): Orphan Drug Approval FDA / EMA - What are the Benefits? What is the Process?

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Mark A. Di Cioccio – Team Consulting

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

1:00 PM – 2:00 PM PDT

CDER’s Product Quality Review of Biologics & Biosimilars: Common Findings, Review Issues and Post-Marketing Recommendations

Location/Room: 202

Presenter: Kelly Nolan, MS – Visterra, Inc

Presenter: William Tubbs – Visterra, Inc

Presenter: Tulay Kilicdagi, MA, RAC-Drugs – Visterra, Inc

Presenter (Remote): Leslie A. Rivera Rosado, PhD – FDA / CDER / OPQ / OPQAIII

Biopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

1:00 PM – 2:00 PM PDT

FDA Forecast: What the FDA has Planned in 2025 for Pharmaceuticals and Biotechnology Products

Location/Room: 201

Presenter: Alexander Gaffney, MS, RAC – AgencyIQ

Presenter: Derrick J. Gingery – Pink Sheet

Presenter: Kelly Griffin, PhD, RAC – PwC

Moderator: Ashley Jones-Mitchell, BS – Accumulus Synergy

Biopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

1:00 PM – 2:00 PM PDT

Regulatory Challenges in New Drug Approval in India and the Way Forward

Location/Room: 203

Presenter: Rashmi Kulshrestha, PhD – REGULATORY WISDOM

Moderator: Chin-Wei Soo, DRSc, FRAPS – Genentech and Roche

Biopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

2:15 PM – 3:15 PM PDT

Accelerating Novel Platforms into the Clinic: Early Experiences with FDA’s Advanced Manufacturing Technology (AMT) Designation and Global Perspectives

Location/Room: 202

Presenter: Angela N. Johnson, PhD, RAC – Cytiva

Presenter: Melanie Sorensen – Cytiva

Presenter: Anabela Marcal – European Medicines Agency

Presenter (Remote): Manuel Osorio, PhD – CBER/FDA

Biopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

2:15 PM – 3:15 PM PDT

Clinical Trials in Pregnancy and Lactation: Time for a Paradigm Shift?

Location/Room: 203

Session Leader: Marie Teil, MD – UCB

Presenter: Anne Lyerly – University of North Carolina at Chapel Hill

Presenter: Tamara Johnson, MD, MS – FDA Center for Drug Evaluation and Research

Presenter (Remote): Corinne de Vries, MA MSc PhD FISPE – European Medicines Agency

Biopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

2:15 PM – 3:15 PM PDT

Quantifying Patient Burden in Protocol Design to Reduce Complexity and Drive Patient-Centricity

Location/Room: 201

Moderator: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceutical, Inc.

Presenter: Kathleen Sheridan, MS – PricewaterhouseCoopers (PwC)

Presenter: Selena Daniels, PharmD, PhD – FDA / CDER

Biopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

4:00 PM – 4:30 PM PDT

Solution Circle (A): AI's Transformative Impact on CMC in Pharmaceuticals

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Anusha Saripalli – Neuron 23

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

4:00 PM – 4:30 PM PDT

Solution Circle (C): Navigating the New Era of Regulatory Affairs: Technology as a Catalyst for Transformation

Location/Room: Exhibit Hall: Solutions Circles Area (C)

Facilitator: Gregory L. Palagi, PMP. CSM, DASM, SSM – Integrated Project Management

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

4:30 PM – 5:30 PM PDT

Failure Is Not An Option: How to Avoid and Recover From an IND Clinical Hold

Location/Room: 202

Session Leader: Linda McBride, R.Ph., RAC – IAA Consulting LLC

Presenter: Tyler C. Vandivort, PhD, RAC, DABT – UCB Biopharma

Presenter: Ben McLaughlin, MSE – Amylaza Consulting, LLC

Biopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

4:30 PM – 5:30 PM PDT

Global Tools to Expedite Advanced Therapy Product Development

Location/Room: 203

Presenter: Kirsten Messmer, PhD, RAC – KM Intel LLC

Presenter: Jessica Boehmer, MBA – US Food and Drug Administration

Presenter (Remote): Caroline Pothet – European Medicines Agency

Biopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

4:30 PM – 5:30 PM PDT

Regulatory Excellence: Japan's Type 1 Cartagena Process for Gene Therapy Products

Location/Room: 201

Session Leader: Carla Gomes, PharmD, MBA – PPD, a part of Thermo Fisher Scientific

Presenter: Machiko Goto, MS in agriculture – PPD-SNBL

Biopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

9:15 AM – 10:30 AM PDT

China Drug Regulatory Pathways

Location/Room: 201

Session Leader: Hamish King, RAC, LLB – Cisema

Presenter: Lisa Huang – PPD Inc

Presenter: Vincent (Wenbo) Zhou – PPD Inc

Biopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

9:15 AM – 10:30 AM PDT

The European Pharmaceutical Legislation Revision – Status Update and Ongoing Challenges

Location/Room: 202

Session Leader: Kirsten Messmer, PhD, RAC – KM Intel LLC

Presenter: Martine Zimmermann, PharmD – IPSEN PHARMA

Presenter: John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority

Presenter (Remote): Christelle Bouygues, PharmD – EMA

Biopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

9:15 AM – 10:30 AM PDT

The MLR Ecosystem: Regulatory and Marketing Collaboration for Brand Success

Location/Room: 203

Presenter: Margot Arntfield, PhD – Klick Health

Biopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

10:35 AM – 11:05 AM PDT

Solution Circle (D): The Impact of Regulatory Control Measures on Access to Opioid Analgesics used for Pain Management in Botswana

Location/Room: Exhibit Hall: Solutions Circles Area (D)

Facilitator: Tshetsana Senau – Botswana Medicines Regulatory Authority

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

11:10 AM – 11:40 AM PDT

Solution Circle (A): ADCs CMC – Regulatory Overreach or as Easy as ABC?

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Michael Craig, BSc Pharm MPSI – Parexel Regulatory Consulting

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

11:10 AM – 11:40 AM PDT

Solution Circle (C): Health Authority Audit and Inspection 101: Best Practices for Research Organizations

Location/Room: Exhibit Hall: Solutions Circles Area (C)

Facilitator: Olivia A. Seale, PMP, MBA, MS Pharmacology – Integrated Project Management

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

11:45 AM – 12:15 PM PDT

Solution Circle (A): China Drug Master Files: Latest Points to Know for Pharma Manufacturers

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Hamish King, RAC, LLB – Cisema

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

12:20 PM – 12:50 PM PDT

Solution Circle (B): USP’s Nitrosamines Exchange: Accelerating Pharmaceutical Quality Strategies

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Naiffer Romero, MSc MPH – U.S. Pharmacopeia

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

12:20 PM – 12:50 PM PDT

Solutions Circle (C): Failure is Not an Option: How to Avoid and Recover from an IND Clinical Hold

Location/Room: Exhibit Hall: Solutions Circles Area (C)

Facilitator: Ben McLaughlin, MSE – Amylaza Consulting, LLC

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

1:00 PM – 2:00 PM PDT

Controlling Pharmaceutical Impurities: A Regulatory Perspective

Location/Room: 203

Presenter: Alex W. Smith, RAC – Hogan Lovells LLP

Presenter: Chris T. Middendorf – Paraxel

Biopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

1:00 PM – 2:00 PM PDT

FDA Efforts to Promote Innovative Medical Product Development

Location/Room: 202

Moderator: Ryan Presto – FDA

Presenter: Wei Liang – FDA/CBER/OTP

Presenter: Cathryn Lee, MSN CRNP – Office of Program Operations, Office of New Drugs, CDER, FDA

Presenter (Remote): Ingrid Markovic, PhD – Food and Drug Administration

Presenter (Remote): Meghana Chalasani – Office of New Drugs, Center for Drug Evaluation and Research, U.S. FDA

Biopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

1:00 PM – 2:00 PM PDT

Regulatory Convergence of Biologics; APEC, ICH, WHO Efforts for LATAM and Around the World

Location/Room: 201

Session Leader: Jared Auclair, PhD – Northeastern University

Presenter: Michelle Limoli, PharmD – US Food and Drug Administration

Presenter: Judith Arcidiacono, MS – US Food and Drug Administration

Presenter: Rominder Singh, PhD – Northeastern University

Biopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

3:15 PM – 4:15 PM PDT

Expanding Global Access to Complex Generics: It is Time for Regulatory Convergence

Location/Room: 201

Presenter: Victor S. Pribluda, PhD – United States Pharmacopeia

Presenter: Chaitanya K. Koduri – United States Pharmacopeia

Presenter: Sarah Ibrahim – FDA/CDER/OGD

Presenter (Remote): Kevin V. Blake, MB BCh BAO PhD – European Medicines Agency

Biopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

3:15 PM – 4:15 PM PDT

Impact of Public-Private Partnerships in Regulatory Science, Drug Development and Regulatory Decision-Making

Location/Room: 202

Moderator: Huong Huynh, PhD – Critical Path Institute

Presenter: Selena Daniels, PharmD, PhD – FDA / CDER

Presenter: Robyn Carson, MPH – Abbvie

Presenter: Cheryl Coon, PhD – Critical Path Institute

Presenter (Remote): Ralf Herold, PhD – European Medicines Agency

Biopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

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 Guidance

Location/Room: 203

Moderator: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceutical, Inc.

Presenter: Mary Nwaneri (Nwokedi), PharmD – PhRMA

Presenter: Ashwin Mathew – GSK

Presenter: Ryan Brown, MPA – H1

Presenter (Remote): Jamie Gamerman, JD – FDA

Biopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

4:30 PM – 5:30 PM PDT

Advancing Gene Therapy: A Holistic Approach to Multicomponent Product Development and Delivery Device Lifecycle

Location/Room: 102

Session Leader: Mary Speagle – TPIreg, Innomar Strategies Inc

Presenter: Martin Nemec – Health Cananda

Presenter: Alyssa Kitchel, PhD – US Food & Drug Administration

Biopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

4:30 PM – 5:30 PM PDT

Considerations for Global Harmonization and Accelerated Drug Development

Location/Room: 202

Presenter: Sue Liu, B.Eng (pharm) MBA RAC – Gilead Sciences

Presenter: Anabela Marcal – European Medicines Agency

Presenter: Jessica Boehmer, MBA – US Food and Drug Administration

Presenter: Michael Rosu-Myles – Health Canada

Biopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

4:30 PM – 5:30 PM PDT

Human Factors Development: Navigating Areas of Ambiguity and Insights for Creating Robust Regulatory Strategies

Location/Room: 203

Session Leader: Nishchay Gupta – Genentech

Presenter: Sherri Biondi, PhD – AstraZeneca

Presenter: Douglass S. Mead, III, RAC – CP Pathways LLC

Biopharmaceuticals (includes Biologics and Drugs)

Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)

Thursday, Sep 19th

1:00 PM – 2:00 PM PDT

“Off-label" Information Communication — Recent Developments and Enforcement Trends in EU and US

Location/Room: 104 B

Session Leader: Monika Bhatt – Siemens Healthineers

Presenter: Richard G. Holborow – BSI

Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)

Thursday, Sep 19th

3:15 PM – 4:15 PM PDT

Precision Medicine Using Companion Diagnostics, AI/ML Modeling, and Digital Health Technology? Buzzwords or Reality?

Location/Room: 102

Presenter: Yoshiko Stowell, PhD, RAC – Kenai Therapeutics

Presenter: Kamana Singh, DVM, MVSc, MBA, RAC – APS Pharma Solutions

Presenter: David Pudwill, MS – FDA Blueprint

Presenter (Remote): Christelle Bouygues, PharmD – EMA

Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)

Thursday, Sep 19th

4:30 PM – 5:30 PM PDT

Addressing Menopause: From Unspoken Reality to Innovation Battlefield

Location/Room: 104 B

Presenter: Andrea Biasiucci, PhD – confinis

Presenter: Niedre M. Heckman, PhD, MPH, FRAPS, RAC, CQA – Takeda

Presenter: Beat U. Steffen, MSc, RAC, FRAPS – confinis ag

Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)

Devices (includes Medical Devices and In Vitro Diagnostics)

Monday, Sep 16th

8:30 AM – 4:00 PM PDT

Artificial Intelligence knocking on your door? The upcoming Artificial Intelligence Act’s Technical Documentation Requirements and how to integrate them into a Medical Device Regulation Submission

Location/Room: 102

Workshop Leader: Sarah Mathew – BSI

Presenter: Daniela Seneca, MEng – BSI

Presenter: Kenneth Fuh, PhD – TÜV SÜD Product Service GmbH

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

Monday, Sep 16th

8:30 AM – 4:00 PM PDT

Survivor: The FDA 510(k) Program Edition (Day 1 of 2)

Location/Room: 202

Presenter: Mark E. DuVal, JD, FRAPS – DuVal & Associates, P.A.

Presenter: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.

Presenter: Kathy Herzog, BSME – DuVal & Associates, P.A.

Presenter: Allison Komiyama, PhD, RAC, FRAPS – RQM+

Presenter: Dongbo Wang, PhD – Histosonics

Presenter (Remote): Ken Skodacek – FDA/CDRH

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

Tuesday, Sep 17th

8:30 AM – 4:00 PM PDT

Basics of Regulatory Strategy for the US & EU for Devices (includes Medical Devices and In Vitro Diagnostics)

Location/Room: 102

Workshop Leader: Ayesha Shah – Veeva Systems

Presenter: Josh Silverstein, PhD – Philips

Presenter: Sabina Hoekstra, PharmD FRAPS – TÜV SÜD Medical Health Services

Presenter (Remote): Christelle Bouygues, PharmD – EMA

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

Tuesday, Sep 17th

8:30 AM – 4:00 PM PDT

MDR Surveillance, Post-Certification and Re-certification Submissions to Notified Bodies: Best Practice for Manufacturers

Location/Room: 104 B

Workshop Leader: Purvi S. Patel, PhD CEng – BSI

Presenter: Rachel Mead, BEng MIET – BSI

Presenter: Vishal Thakker, MEng – BSI

Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS

Presenter: Duncan McPherson, MBBS FRCA – LNE-GMED-UK

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

Tuesday, Sep 17th

8:30 AM – 4:00 PM PDT

Survivor: The FDA 510(k) Program Edition (Day 2 of 2)

Location/Room: 202

Presenter: Mark E. DuVal, JD, FRAPS – DuVal & Associates, P.A.

Presenter: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.

Presenter: Kathy Herzog, BSME – DuVal & Associates, P.A.

Presenter: Allison Komiyama, PhD, RAC, FRAPS – RQM+

Presenter: Dongbo Wang, PhD – Histosonics

Presenter (Remote): Ken Skodacek – FDA/CDRH

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

9:15 AM – 10:30 AM PDT

Future State of Europe

Location/Room: 102

Moderator: Sabina Hoekstra, PharmD FRAPS – TÜV SÜD Medical Health Services

Moderator: Gert W. Bos, MSc, PhD and FRAPS – Qserve Group

Presenter: Royth P. von Hahn, PhD – TÜV SÜD Product Services

Presenter: Leo Hovestadt – Elekta

Presenter (Remote): Flora Giorgio – European Commission

Devices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

9:15 AM – 10:30 AM PDT

Standardization of Clinical Study Design

Location/Room: 104 C

Presenter: Bassil Akra – AKRA TEAM

Presenter: Diane M. Legere, RN MSc APCCN – DNV Product Assurance AS

Presenter (Remote): Danielle Giroud, MSci, MBA – MD-CLINICALS SA

Presenter (Remote): Theodor Framke

Devices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

10:35 AM – 11:05 AM PDT

Solution Circle (A): How to Prepare for a Successful FDA Q-sub

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Lucy Tan – Abbott

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

10:35 AM – 11:05 AM PDT

Solution Circle (B): Is this AI/ML Software Application a Medical device? Applying FDA Guidance Documents and On-Line Resources

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Alex Friedman, PhD, RAC – Beckman Coulter

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

11:10 AM – 11:40 AM PDT

Solution Circle (A): Evaluating the Quality of Real-World Evidence Used to Support Regulatory Decision-Making for Medical Devices

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Michelle Kavin, PhD, PA-C – Johnson and Johnson

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

11:10 AM – 11:40 AM PDT

Solution Circle (B): Strategies on Tackling Clinical Data Gaps Between Different Designs of Medical Devices (B):

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Matthias Fink, MD – Akra Team Inc.

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

11:45 AM – 12:15 PM PDT

Solution Circle (B): Establishing a Regulatory Talent Pipeline Strategy for Industry 4.0

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Filsun Moussa, MBA, PMP – Medtronic

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

11:45 AM – 12:15 PM PDT

Solution Circle (D): Post-Market 510(k) and De Novo Change Management: Cinderella Strategies for Keeping Your House in Order

Location/Room: Exhibit Hall: Solutions Circles Area (D)

Facilitator: Kathy Herzog, BSME – DuVal & Associates, P.A.

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

12:20 PM – 12:50 PM PDT

Solution Circle (A): LDT, RUO, IVD: What Regulatory Status for Tests Used in European Clinical Trial?

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Christèle East – Namsa

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

1:00 PM – 2:00 PM PDT

Digital Labeling and eIFU Enhance Customer Experience, Facilitate Compliance, and Improve Operational Efficiencies and Agility

Location/Room: 102

Presenter: Nataliya Deych – Edwards Lifesciences Sarl

Presenter: Glenda Marsh – Johnson & Johnson Medtech

Presenter (Remote): Elizabeth Scanlan, MSc, PhD – European Medicines Agency

Devices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

1:00 PM – 2:00 PM PDT

Examining Methods to Ensure Data Quality and Privacy Considerations for AI-Enabled Medical Devices

Location/Room: 104 C

Session Leader: Shirley Furesz, PhD, RAC – Innomar Strategies Inc.

Presenter: Stefan Bolleininger – be-on-Quality GmbH

Devices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

1:00 PM – 2:00 PM PDT

The Importance of Data Standardization in Clinical Trials; An Update From an MDIC Supported Project

Location/Room: 104 B

Session Leader: John Acampado, MBA, MPH – Veeva Systems

Presenter: Pipper White, MSc – MDIC

Presenter: Nick Decker – Roche

Devices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

2:15 PM – 3:15 PM PDT

2024 LDT Regulatory Shifts: Understanding Impacts & Strategic Adaptation for Stakeholders

Location/Room: 101

Presenter: Aditi Khurana, RAC, PMP, CG, MB – Summit Therapeutics

Presenter: Cynthe Sims, PhD, HCLD(ABB) – Blackhawk Genomics

Presenter: Monika Bhatt – Siemens Healthineers

Devices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

2:15 PM – 3:15 PM PDT

Monitoring AI Devices

Location/Room: 104 A

Presenter: Jithesh Veetil, PhD – MDIC

Presenter: Jay Nayar, RAC – Google

Presenter: Tealman Bjoraker – Medtronic

Devices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

2:15 PM – 3:15 PM PDT

UKCA & Market Developments

Location/Room: 104 C

Moderator: Sue Spencer – Qserve Group

Presenter: Monisha Phillips, PhD – TÜV SÜD

Presenter: Vishal Thakker, MEng – BSI

Presenter: Robert Reid – MHRA

Presenter: Stephen Lee – ABHI

Devices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

4:00 PM – 4:30 PM PDT

Solution Circle (B): Clinical Decision Support Software vs. Software as a Medical Device

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Laura Szkolar-Sienkiewicz, PhD, PMP, RAC – Microsoft

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

4:30 PM – 5:30 PM PDT

Emerging Standard Developments in PFAS

Location/Room: 101

Session Leader: Catherine V. Moustakas – DEKRA Certification

Presenter: Lindsey Zocolo – TUV SUD

Devices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

4:30 PM – 5:30 PM PDT

Manufacturer's Approach to Advancing Health Equity for Medical Devices

Location/Room: 104 A

Presenter/Moderator: Amra Racic – Veeva Systems

Presenter: Maria Restrepo – Medtronic

Presenter: Lee Evans – Philips

Devices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

4:30 PM – 5:30 PM PDT

What is New With Clinical Data Under the MDR? Interactive Panel Session With Notified Bodies

Location/Room: 102

Session Leader: Matthias Fink, MD – Akra Team Inc.

Presenter: Richard G. Holborow – BSI

Presenter: Christoph Ziskoven, MD – TÜV Rheinland LGA Products GmbH

Presenter: Ulrich Nitsche, MD – TÜV SÜD Product Service GmbH

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

9:15 AM – 10:30 AM PDT

Initial Experience with Predetermined Change Control Plans and FDA’s PCCP Guidance / Principles

Location/Room: 104 C

Moderator: Alex W. Smith, RAC – Hogan Lovells LLP

Presenter: Yarmela Pavlovic – Medtronic

Presenter: Shilpa Prem, J.D. – Amazon

Presenter: Christopher Phillips, MSHS, RAC, CMDA – Epitel

Presenter (Remote): Jessica Paulsen – FDA

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

9:15 AM – 10:30 AM PDT

Notified Body Forum: State of Play EU MDR and EU IVDR

Location/Room: 102

Session Leader: Bassil Akra – AKRA TEAM

Presenter: Sabina Hoekstra, PharmD FRAPS – TÜV SÜD Medical Health Services

Presenter: Gert W. Bos, MSc, PhD and FRAPS – Qserve Group

Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS

Presenter: Suzanne Halliday, PhD – BSI

Presenter: James Dewar – Scarlet

Presenter: Tom Patten, MSc – GMED

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

9:15 AM – 10:30 AM PDT

Submission Strategies for Cybersecurity: Meeting the New Bar

Location/Room: 101

Session Leader: Rene' Hardee – MedSec

Presenter: Chris Reed – Medtronic

Presenter: Edison Alvarez – BD

Presenter: Chad Williams – Bayer

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

10:35 AM – 11:05 AM PDT

Solution Circle (B): National Registrations and Other National Differences in the EU

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Ludger J. Moeller – MDSS GmbH

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

10:35 AM – 11:05 AM PDT

Solution Circle (C): Submission of Implantable Medical Devices in Brazil: ANVISA's Class III and IV Requirements

Location/Room: Exhibit Hall: Solutions Circles Area (C)

Facilitator: Patricia Luchiari Verrone – Vera Rosas Group

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

11:10 AM – 11:40 AM PDT

Solution Circle (D): PCCP - Predetermined Change Control Plan - Strategy With Case Studies for Medical Devices

Location/Room: Exhibit Hall: Solutions Circles Area (D)

Facilitator: Abhineet Johri – Siemens Healthineers

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

11:45 AM – 12:15 PM PDT

Solution Circle (B): Emerging Standard Developments in PFAS

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Catherine V. Moustakas – DEKRA Certification

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

11:45 AM – 12:15 PM PDT

Solution Circle (C): Transformative Trends: Navigating the Evolving Regulatory Path for Laboratory Developed Tests

Location/Room: Exhibit Hall: Solutions Circles Area (C)

Facilitator: Ayse Demircan

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

12:20 PM – 12:50 PM PDT

Solution Circle (A): Charting the Course: Interactive Breakout Session on Navigating FDA Communication

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Hilary A. Baldwin – Eximis Surgical

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

1:00 PM – 2:00 PM PDT

Best Practices for 510(k) Submissions Utilizing eSTAR

Location/Room: 104 C

Session Leader: Surina Gulati, MBEE – Align Technology

Presenter: Melissa A. Hall, MS BME – Statera Regulatory Consulting

Presenter: Prithul Bom, MS, MBA, RAC (US, EU) – Regulatory Technology Services (RTS)

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

1:00 PM – 2:00 PM PDT

Start Ups | Unlocking Success in MedTech Innovation: Navigating Regulatory Challenges for Startups and Spin-Offs

Location/Room: 101

Presenter: Robert Paassen, MSc – Qserve

Presenter: Matthias Fink, MD – Akra Team Inc.

Presenter: Rene Pot, MSc – Indigo

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

1:00 PM – 2:00 PM PDT

Structured Dialogue for (IVD) Medical Devices in Europe: Now Will Finally Get Some Answers

Location/Room: 102

Presenter: Alex Laan – BSI

Presenter: Sabina Hoekstra, PharmD FRAPS – TÜV SÜD Medical Health Services

Presenter: Additional Slides (Resources)

Presenter: Volker Schluter, PhD – TüV Rheinland

Presenter: Sue Spencer – Qserve Group

Moderator: Francis Dekker, PhD – Thermo Fisher Scientific

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

2:30 PM – 3:00 PM PDT

Solution Circle (A): Navigating Regulatory Pathways: When to Submit a Special 510(k) vs. Internal Letter-to-File for Device Changes (Bo

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Crew J. Weunski, M.S., RAC-Devices – MediView XR, Inc.

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

3:15 PM – 4:15 PM PDT

Artificial Intelligence – Medical Devices and IVD’s conformity Assessment and CE Marking

Location/Room: 104 B

Session Leader: Leo Hovestadt – Elekta

Presenter: Sarah Mathew – BSI

Presenter: Kenneth Fuh, PhD – TÜV SÜD Product Service GmbH

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

3:15 PM – 4:15 PM PDT

Updates From the US and EU on Furthering the Advancements of Medical Device Development in Pediatrics

Location/Room: 104 C

Session Leader: Amra Racic – Veeva Systems

Presenter: Gert W. Bos, MSc, PhD and FRAPS – Qserve Group

Presenter (Remote): Vasum Peiris, MD, MPH, FAAP, FACC, FASE – FDA

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

3:15 PM – 4:15 PM PDT

Using Foreign Data to and From China

Location/Room: 101

Presenter: Grace Fu Palma, MBA – China Med Device, LLC

Presenter/Moderator: Niedre M. Heckman, PhD, MPH, FRAPS, RAC, CQA – Takeda

Presenter: wenkai ma – Abbvie

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

4:30 PM – 5:30 PM PDT

A Path to Faster Breakthrough Device Commercialization - CDRH's Total Product Life Cycle Advisory Program (TAP)

Location/Room: 201

Session Leader: Adrienne Lenz, RAC – Hyman, Phelps & McNamara, P.C.

Presenter: Laura Gottschalk, PhD – FDA

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

4:30 PM – 5:30 PM PDT

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Location/Room: 101

Session Leader: William M. Sutton – Mid-Link Group

Devices (includes Medical Devices and In Vitro Diagnostics)

Exhibit Hall

Tuesday, Sep 17th

6:00 PM – 7:30 PM PDT

Opening Reception & Welcome in the Exhibit Hall

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Wednesday, Sep 18th

10:00 AM – 4:30 PM PDT

Career Central Hours (Exhibit Hall: Booth 349)

Location/Room: Exhibit Hall: Career Central (Booth 349)

Exhibit Hall

Supported By

Wednesday, Sep 18th

10:30 AM – 11:00 AM PDT

Refreshment Break in the Exhibit Hall

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Supported by

Wednesday, Sep 18th

10:30 AM – 1:00 PM PDT

Exclusive Exhibit Hall Hours: Networking & Presentations

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Wednesday, Sep 18th

10:30 AM – 4:30 PM PDT

Certification Lounge Hours (Exhibit Hall: Booth 225)

Location/Room: Exhibit Hall: Certification Lounge (Booth 225)

Exhibit Hall

Wednesday, Sep 18th

10:30 AM – 4:30 PM PDT

Exhibit Hall Open

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Wednesday, Sep 18th

10:30 AM – 4:30 PM PDT

Headshot Lounge Hours (Exhibit Hall: Booth 1049)

Location/Room: Exhibit Hall: Headshot Lounge (Booth 1049)

Exhibit Hall

Supported by

Wednesday, Sep 18th

10:30 AM – 4:30 PM PDT

RAPS Central Hours (Exhibit Hall: Booth 813)

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Exhibit Hall

Wednesday, Sep 18th

10:30 AM – 4:30 PM PDT

Regulatory Cares Community Giveback Booth Hours (Exhibit Hall: Booth 425)

Location/Room: Exhibit Hall: Giveback Booth (Booth 425)

Exhibit Hall

Wednesday, Sep 18th

11:30 AM – 1:00 PM PDT

Networking Lunch in the Exhibit Hall

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Wednesday, Sep 18th

3:00 PM – 3:30 PM PDT

Refreshment Break in the Exhibit Hall

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Supported By

Wednesday, Sep 18th

3:15 PM – 4:30 PM PDT

Exclusive Exhibit Hall Hours: Networking & Presentations

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Thursday, Sep 19th

10:30 AM – 1:00 PM PDT

Exclusive Exhibit Hall Hours: Networking & Presentations

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Thursday, Sep 19th

10:30 AM – 3:30 PM PDT

Career Central Hours (Exhibit Hall: Booth 349)

Location/Room: Exhibit Hall: Career Central (Booth 349)

Exhibit Hall

Supported By

Thursday, Sep 19th

10:30 AM – 3:30 PM PDT

Certification Lounge Hours (Exhibit Hall: Booth 225)

Location/Room: Exhibit Hall: Certification Lounge (Booth 225)

Exhibit Hall

Thursday, Sep 19th

10:30 AM – 3:30 PM PDT

Exhibit Hall Open

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Thursday, Sep 19th

10:30 AM – 3:30 PM PDT

Headshot Lounge Hours (Exhibit Hall: Booth 1049)

Location/Room: Exhibit Hall: Headshot Lounge (Booth 1049)

Exhibit Hall

Supported by

Thursday, Sep 19th

10:30 AM – 3:30 PM PDT

RAPS Central Hours (Exhibit Hall: Booth 813)

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Exhibit Hall

Thursday, Sep 19th

10:30 AM – 3:30 PM PDT

RAPS Community Giveback Hours (Exhibit Hall: Booth 425)

Location/Room: Exhibit Hall: Giveback Booth (Booth 425)

Exhibit Hall

Thursday, Sep 19th

11:30 AM – 1:00 PM PDT

Networking Lunch in the Exhibit Hall

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Thursday, Sep 19th

2:00 PM – 2:30 PM PDT

Refreshment Break in the Exhibit Hall

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Supported by

Thursday, Sep 19th

2:00 PM – 3:15 PM PDT

Exclusive Exhibit Hall Hours: Networking & Presentations

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Exhibit Hall: Career Central

Wednesday, Sep 18th

11:00 AM – 11:30 AM PDT

Career Central Stage: Get Certified in Regulatory Affairs: Get Your RAC!

Location/Room: Exhibit Hall: Career Central (Booth 349)

Presenter: Emily Nesbitt, RAC – Johnson & Johnson

Presenter: Grace Powers, FRAPS, MS, MBA, RAC – Powers Regulatory Consulting

Presenter: Lori Berends, RAC – Boston Scientific

Exhibit Hall: Career Central

Supported By

Wednesday, Sep 18th

11:30 AM – 12:30 PM PDT

RAPS “Speed Mentoring” in Career Central

Location/Room: Exhibit Hall: Career Central (Booth 349)

Exhibit Hall: Career CentralNetworking Opportunity

Supported By

Wednesday, Sep 18th

11:45 AM – 12:15 PM PDT

Career Central Stage: RAPS 2024 Global Compensation and Scope of Practice Report: Learn How You Measure Up

Location/Room: Exhibit Hall: Career Central (Booth 349)

Presenter: Denise Fulton – RAPS

Exhibit Hall: Career Central

Supported By

Wednesday, Sep 18th

3:30 PM – 4:00 PM PDT

Career Central Stage: Get Your Regulatory Compliance Certification (RCC) Introducing Two new Certifications from RAPS

Location/Room: Exhibit Hall: Career Central (Booth 349)

Presenter: Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS

Exhibit Hall: Career Central

Supported By

Wednesday, Sep 18th

3:30 PM – 4:30 PM PDT

RAPS Chapter/LNG Meet and Greet in Career Central

Location/Room: Exhibit Hall: Career Central (Booth 349)

Exhibit Hall: Career CentralNetworking Opportunity

Supported By

Thursday, Sep 19th

11:30 AM – 12:00 PM PDT

Career Central Stage: Opportunities for Professionals & Students of Graduate Regulatory Education

Location/Room: Exhibit Hall: Career Central (Booth 349)

Presenter: Susan Bain, DRSc, MSc, DRSc – University of Southern California

Presenter: Emil Wang – U.S. Public Health Service

Student FocusExhibit Hall: Career Central

Supported By

Thursday, Sep 19th

11:30 AM – 12:30 PM PDT

RAPS “Speed Mentoring” in Career Central

Location/Room: Exhibit Hall: Career Central (Booth 349)

Exhibit Hall: Career CentralNetworking Opportunity

Supported By

Thursday, Sep 19th

12:15 PM – 12:25 PM PDT

Career Central Stage: Student Capstone Presentation: Global MedRegs (Global Regulatory Requirements for Medical Devices) "Simplifying your Regulatory Journey Across International Markets”

Location/Room: Exhibit Hall: Career Central (Booth 349)

Graduate Student Presenter: Akash Kirani Adarshakumar, n/a – NORTHEASTERN UNIVERSITY

Student FocusExhibit Hall: Career Central

Supported By

Exhibit Hall: RAPS Central

Wednesday, Sep 18th

10:45 AM – 11:15 AM PDT

RAPS BOD Roundtable: Emerging Regulatory Trends

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Guest Speaker: Daniela Drago, RAC, FRAPS – NDA Partners

Guest Speaker: Lawrence E. Liberti, MSc, PhD

Guest Speaker: Diana Salditt, FRAPS – Salditt Regulatory Consulting LLC

Guest Speaker: Kimberly A. Trautman, MS – RAPS BoD

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

Wednesday, Sep 18th

12:30 PM – 1:00 PM PDT

New! RAPS Mentoring Program

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Networking OpportunityExhibit Hall: RAPS Central

Wednesday, Sep 18th

3:00 PM – 3:30 PM PDT

RAPS Fellows: How to Maximize the Application Process

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Exhibit Hall: RAPS CentralNetworking Opportunity

Wednesday, Sep 18th

3:45 PM – 4:15 PM PDT

RAPS BOD Roundtable: The Futuristic Regulatory Professional

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Guest Speaker: Carol M. Cooper, MS, RAC, IM(ASCP), RM(AAM) – CM Cooper & Associates

Guest Speaker: Gert W. Bos, MSc, PhD and FRAPS – Qserve Group

Guest Speaker: Lawrence E. Liberti, MSc, PhD

Guest Speaker: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

Thursday, Sep 19th

10:45 AM – 11:15 AM PDT

RAPS BOD Roundtable: Volunteering

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Guest Speaker: Patricia Castro – Abbott

Guest Speaker: Jocelyn Jennings, MS, RAC, FRAPS – Mycovia Pharmaceuticals, Inc.

Guest Speaker: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

Thursday, Sep 19th

11:30 AM – 12:00 PM PDT

RAPS BOD Roundtable: The Futuristic Regulatory Professional

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Guest Speaker: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho

Guest Speaker: Kimberly A. Trautman, MS – RAPS BoD

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

Thursday, Sep 19th

2:30 PM – 3:00 PM PDT

RAPS BOD Roundtable: I Am Regulatory

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Guest Speaker: Jocelyn Jennings, MS, RAC, FRAPS – Mycovia Pharmaceuticals, Inc.

Guest Speaker: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

Exhibit Hall: Solutions Circle

Wednesday, Sep 18th

10:35 AM – 11:05 AM PDT

Solution Circle (A): How to Prepare for a Successful FDA Q-sub

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Lucy Tan – Abbott

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

10:35 AM – 11:05 AM PDT

Solution Circle (B): Is this AI/ML Software Application a Medical device? Applying FDA Guidance Documents and On-Line Resources

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Alex Friedman, PhD, RAC – Beckman Coulter

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

10:35 AM – 11:05 AM PDT

Solution Circle (C): Leveraging Dual RAC Certification to become an Expert in Enhancing the Success of Combination Product Development.

Location/Room: Exhibit Hall: Solutions Circles Area (C)

Facilitator: Charles Nnabuife, B.Pharm, MBA, RAC-Drugs – Veristat Inc

Exhibit Hall: Solutions CircleOther

Wednesday, Sep 18th

10:35 AM – 11:05 AM PDT

Solution Circle (D): Maximizing the Potential of Meetings with the FDA

Location/Room: Exhibit Hall: Solutions Circles Area (D)

Facilitator: Hagit Marchaim, PhD – HMC-regulation; Dr. Hagit Marchaim RA and Drug Development Consulting

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

11:10 AM – 11:40 AM PDT

Solution Circle (A): Evaluating the Quality of Real-World Evidence Used to Support Regulatory Decision-Making for Medical Devices

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Michelle Kavin, PhD, PA-C – Johnson and Johnson

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

11:10 AM – 11:40 AM PDT

Solution Circle (B): Strategies on Tackling Clinical Data Gaps Between Different Designs of Medical Devices (B):

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Matthias Fink, MD – Akra Team Inc.

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

11:10 AM – 11:40 AM PDT

Solution Circle (C): The Right Balance Between Business, Science, and Regulation in Managing Supply Chains

Location/Room: Exhibit Hall: Solutions Circles Area (C)

Facilitator: Lopa Bakrania, PhD, RAC – Biohaven Pharmaceuticals

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

11:45 AM – 12:15 PM PDT

Solution Circle (A): Career Pathways in Regulatory Affairs

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Jay Patel, MS – KPMG

Exhibit Hall: Solutions CircleOther

Wednesday, Sep 18th

11:45 AM – 12:15 PM PDT

Solution Circle (B): Establishing a Regulatory Talent Pipeline Strategy for Industry 4.0

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Filsun Moussa, MBA, PMP – Medtronic

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

11:45 AM – 12:15 PM PDT

Solution Circle (C): Phase and Product Appropriate Regulatory Strategies in Impurity Characterizations and Controls

Location/Room: Exhibit Hall: Solutions Circles Area (C)

Facilitator: Hai Wang, PhD – El Vista Consulting LLC

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

11:45 AM – 12:15 PM PDT

Solution Circle (D): Post-Market 510(k) and De Novo Change Management: Cinderella Strategies for Keeping Your House in Order

Location/Room: Exhibit Hall: Solutions Circles Area (D)

Facilitator: Kathy Herzog, BSME – DuVal & Associates, P.A.

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

12:20 PM – 12:50 PM PDT

Solution Circle (A): LDT, RUO, IVD: What Regulatory Status for Tests Used in European Clinical Trial?

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Christèle East – Namsa

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

12:20 PM – 12:50 PM PDT

Solution Circle (B): Orphan Drug Approval FDA / EMA - What are the Benefits? What is the Process?

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Mark A. Di Cioccio – Team Consulting

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

4:00 PM – 4:30 PM PDT

Solution Circle (A): AI's Transformative Impact on CMC in Pharmaceuticals

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Anusha Saripalli – Neuron 23

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Sep 18th

4:00 PM – 4:30 PM PDT

Solution Circle (B): Clinical Decision Support Software vs. Software as a Medical Device

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Laura Szkolar-Sienkiewicz, PhD, PMP, RAC – Microsoft

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Sep 18th

4:00 PM – 4:30 PM PDT

Solution Circle (C): Navigating the New Era of Regulatory Affairs: Technology as a Catalyst for Transformation

Location/Room: Exhibit Hall: Solutions Circles Area (C)

Facilitator: Gregory L. Palagi, PMP. CSM, DASM, SSM – Integrated Project Management

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

10:35 AM – 11:05 AM PDT

Solution Circle (A): How to Break Through the Regulatory Glass Ceiling and Get Hired!

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Ritam Priya, BA, MBA – Novarum MDRQ Consulting

Exhibit Hall: Solutions CircleOther

Thursday, Sep 19th

10:35 AM – 11:05 AM PDT

Solution Circle (B): National Registrations and Other National Differences in the EU

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Ludger J. Moeller – MDSS GmbH

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

10:35 AM – 11:05 AM PDT

Solution Circle (C): Submission of Implantable Medical Devices in Brazil: ANVISA's Class III and IV Requirements

Location/Room: Exhibit Hall: Solutions Circles Area (C)

Facilitator: Patricia Luchiari Verrone – Vera Rosas Group

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

10:35 AM – 11:05 AM PDT

Solution Circle (D): The Impact of Regulatory Control Measures on Access to Opioid Analgesics used for Pain Management in Botswana

Location/Room: Exhibit Hall: Solutions Circles Area (D)

Facilitator: Tshetsana Senau – Botswana Medicines Regulatory Authority

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

11:10 AM – 11:40 AM PDT

Solution Circle (A): ADCs CMC – Regulatory Overreach or as Easy as ABC?

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Michael Craig, BSc Pharm MPSI – Parexel Regulatory Consulting

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

11:10 AM – 11:40 AM PDT

Solution Circle (B): Diversity in Clinical Trials

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Anagha Shende, MBBS, MD – Lexicon Pharmaceuticals Inc.

Exhibit Hall: Solutions CircleOther

Thursday, Sep 19th

11:10 AM – 11:40 AM PDT

Solution Circle (C): Health Authority Audit and Inspection 101: Best Practices for Research Organizations

Location/Room: Exhibit Hall: Solutions Circles Area (C)

Facilitator: Olivia A. Seale, PMP, MBA, MS Pharmacology – Integrated Project Management

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

11:10 AM – 11:40 AM PDT

Solution Circle (D): PCCP - Predetermined Change Control Plan - Strategy With Case Studies for Medical Devices

Location/Room: Exhibit Hall: Solutions Circles Area (D)

Facilitator: Abhineet Johri – Siemens Healthineers

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

11:45 AM – 12:15 PM PDT

Solution Circle (A): China Drug Master Files: Latest Points to Know for Pharma Manufacturers

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Hamish King, RAC, LLB – Cisema

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

11:45 AM – 12:15 PM PDT

Solution Circle (C): Transformative Trends: Navigating the Evolving Regulatory Path for Laboratory Developed Tests

Location/Room: Exhibit Hall: Solutions Circles Area (C)

Facilitator: Ayse Demircan

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

12:20 PM – 12:50 PM PDT

Solution Circle (A): Charting the Course: Interactive Breakout Session on Navigating FDA Communication

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Hilary A. Baldwin – Eximis Surgical

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

12:20 PM – 12:50 PM PDT

Solution Circle (B): USP’s Nitrosamines Exchange: Accelerating Pharmaceutical Quality Strategies

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Naiffer Romero, MSc MPH – U.S. Pharmacopeia

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

12:20 PM – 12:50 PM PDT

Solutions Circle (C): Failure is Not an Option: How to Avoid and Recover from an IND Clinical Hold

Location/Room: Exhibit Hall: Solutions Circles Area (C)

Facilitator: Ben McLaughlin, MSE – Amylaza Consulting, LLC

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Thursday, Sep 19th

2:30 PM – 3:00 PM PDT

Solution Circle (A): Navigating Regulatory Pathways: When to Submit a Special 510(k) vs. Internal Letter-to-File for Device Changes (Bo

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Crew J. Weunski, M.S., RAC-Devices – MediView XR, Inc.

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Sep 19th

2:30 PM – 3:00 PM PDT

Solution Circle (B): Taking your Skills to the Next Level: Transform your Career

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Kiran Gulati, MBA, Exemplar Lead Auditor – UCSC Silicon Valley Extension

Exhibit Hall: Solutions CircleOther

Health Authority Session

Wednesday, Sep 18th

9:15 AM – 10:30 AM PDT

Health Authority Forum: Europe Forum, European Medicines Agency (EMA) & European Regulatory Network

Location/Room: 104 A

Presenter: Sabine Haubenreisser, MSc, PhD – European Medicines Agency

Presenter: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency

Presenter: Anabela Marcal – European Medicines Agency

Presenter (Remote): Caroline Pothet – European Medicines Agency

Health Authority Session

Wednesday, Sep 18th

1:00 PM – 2:00 PM PDT

Conversations That Matter - Interactions With Health Authorities: Medical Devices and IVDs

Location/Room: 104 A

Moderator: Jethro Ekuta, DVM, PhD, RAC, FRAPS – Alexion, AstraZeneca Rare Disease

Panelist: Judith Arcidiacono, MS – US Food and Drug Administration

Panelist: Suzanne Halliday, PhD – BSI

Panelist: Sabine Haubenreisser, MSc, PhD – European Medicines Agency

Panelist: Sabina Hoekstra, PharmD FRAPS – TÜV SÜD Medical Health Services

Panelist: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency

Health Authority Session

Wednesday, Sep 18th

2:15 PM – 3:15 PM PDT

Health Authority Forum: CDRH - FDA's Center for Devices and Radiological Health

Location/Room: 102

Presenter (Remote): Michelle Tarver, MD, PhD – U.S. Food and Drug Administration/ CDRH

Presenter (Remote): Felipe Aguel – FDA CDRH

Presenter (Remote): Angela Krueger – US Food and Drug Administration

Presenter (Remote): April Marrone

Panel Facilitator: Megha Iyer, MSc, MS, RAC, FRAPS – Thermo Fisher Scientific

Health Authority Session

Thursday, Sep 19th

9:15 AM – 10:30 AM PDT

Conversations That Matter - Interactions With Health Authorities: Drugs, Biologics and Combination Products

Location/Room: 104 A

Moderator: Jethro Ekuta, DVM, PhD, RAC, FRAPS – Alexion, AstraZeneca Rare Disease

Panelist (Remote): Peter W. Marks, MD, PhD – United States Food and Drug Administration

Panelist: Sabine Haubenreisser, MSc, PhD – European Medicines Agency

Panelist: Anabela Marcal – European Medicines Agency

Panelist: Tshetsana Senau – Botswana Medicines Regulatory Authority

Health Authority Session

Thursday, Sep 19th

3:15 PM – 4:15 PM PDT

Health Authority Forum: CBER - FDA’s Center for Biologics Evaluation and Research (CBER)

Location/Room: 104 A

Presenter (Remote): Peter W. Marks, MD, PhD – United States Food and Drug Administration

Presenter: Christopher Joneckis, PhD – US FDA

Moderator: Katie Rivers, MS – FDA/CBER/ORO/DROP/RABOB

Panel Facilitator: Tyler C. Vandivort, PhD, RAC, DABT – UCB Biopharma

Health Authority Session

Thursday, Sep 19th

4:30 PM – 5:30 PM PDT

Health Authority Forum: CDER - FDA's Center for Drug Evaluation and Research

Location/Room: 104 A

Presenter (Remote): Peter P. Stein, MD – Office of New Drugs, CDER, FDA

Panel Facilitator: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceutical, Inc.

Health Authority Session

Thursday, Sep 19th

4:30 PM – 5:30 PM PDT

International Harmonization & Regulator Forum

Location/Room: 104 C

Moderator: Olga Van Grol-Lawlor, MPHIL – Boston Scientific

Presenter: Jasjit Baveja, PhD – Medical Technology Association of Australia

Presenter: Tshetsana Senau – Botswana Medicines Regulatory Authority

Presenter (Remote): Paulyne Wairimu – Pharmacy and Poisons Board, Kenya

Panelist (Remote): Faiza Alzadjali

Presenter: Stephen Lee – ABHI

Health Authority Session

Networking Opportunity

Tuesday, Sep 17th

8:00 AM – 5:00 PM PDT

RAPS Wellness Challenge

Location/Room: Main Lobby (Tech Support Desk Area)

Networking Opportunity

Tuesday, Sep 17th

4:30 PM – 5:00 PM PDT

Convergence 2024 Welcome!

Location/Room: Level 2: Grand Ballroom

Presenter: Gert W. Bos, MSc, PhD and FRAPS – Qserve Group

Presenter: Bill McMoil, MBA – Regulatory Affairs Professionals Society (RAPS)

Presenter: Megha Iyer, MSc, MS, RAC, FRAPS – Thermo Fisher Scientific

Presenter: Chris Whalley – Pfizer

Sponsor Speaker: Punya Abbhi – Celegence

Networking Opportunity

Supported By

Tuesday, Sep 17th

5:00 PM – 6:00 PM PDT

RAPS Convergence 2024 Opening Plenary Session: Cross-Industry Insights: Leveraging AI to Elevate NextGen Regulatory

Location/Room: Level 2: Grand Ballroom

Moderator: Megha Iyer, MSc, MS, RAC, FRAPS – Thermo Fisher Scientific

Panelist: Michelle Jump, RAC – MedSec LLC

Panelist: Ryan Kurtzman – City of Long Beach

Panelist: Jay H. Mashburn, PhD, RPh – Recursion Pharmaceuticals, Inc.

Panelist: Bradley M. Thompson, MBA, JD, RAC – Epstein, Becker & Green

Networking Opportunity

Tuesday, Sep 17th

6:00 PM – 7:30 PM PDT

Opening Reception & Welcome in the Exhibit Hall

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Wednesday, Sep 18th

8:00 AM – 8:15 AM PDT

RAPS Convergence 2024 Plenary Session: Morning Welcome and Patient-Centered Health Award Presentation

Location/Room: Level 2: Grand Ballroom

Presenter: Jethro Ekuta, DVM, PhD, RAC, FRAPS – Alexion, AstraZeneca Rare Disease

Presenter: Bill McMoil, MBA – Regulatory Affairs Professionals Society (RAPS)

Award Recipient: Cheryl Coon, PhD – Critical Path Institute

Networking Opportunity

Wednesday, Sep 18th

8:00 AM – 5:00 PM PDT

RAPS Wellness Challenge

Location/Room: Main Lobby (Tech Support Desk Area)

Networking Opportunity

Wednesday, Sep 18th

8:15 AM – 9:00 AM PDT

RAPS Convergence 2024 Plenary Session: Challenges in Developing Medical Technologies for Unmet Medical Needs

Location/Room: Level 2: Grand Ballroom

Moderator: João Duarte, MSc MPharm – Ipsen

Panelist: Cheryl Coon, PhD – Critical Path Institute

Panelist: Karl-Heinz Huemer – khhconsulting

Panelist: Allison Komiyama, PhD, RAC, FRAPS – RQM+

Panelist: Justin West, MD – KCNT1 Epilepsy Foundation

Networking Opportunity

Wednesday, Sep 18th

10:30 AM – 11:00 AM PDT

Refreshment Break in the Exhibit Hall

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Supported by

Wednesday, Sep 18th

10:30 AM – 1:00 PM PDT

Exclusive Exhibit Hall Hours: Networking & Presentations

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Wednesday, Sep 18th

10:30 AM – 4:30 PM PDT

Exhibit Hall Open

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Wednesday, Sep 18th

10:45 AM – 11:15 AM PDT

RAPS BOD Roundtable: Emerging Regulatory Trends

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Guest Speaker: Daniela Drago, RAC, FRAPS – NDA Partners

Guest Speaker: Lawrence E. Liberti, MSc, PhD

Guest Speaker: Diana Salditt, FRAPS – Salditt Regulatory Consulting LLC

Guest Speaker: Kimberly A. Trautman, MS – RAPS BoD

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

Wednesday, Sep 18th

11:30 AM – 12:30 PM PDT

RAPS “Speed Mentoring” in Career Central

Location/Room: Exhibit Hall: Career Central (Booth 349)

Exhibit Hall: Career CentralNetworking Opportunity

Supported By

Wednesday, Sep 18th

11:30 AM – 1:00 PM PDT

Networking Lunch in the Exhibit Hall

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Wednesday, Sep 18th

12:30 PM – 1:00 PM PDT

New! RAPS Mentoring Program

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Networking OpportunityExhibit Hall: RAPS Central

Wednesday, Sep 18th

3:00 PM – 3:30 PM PDT

Refreshment Break in the Exhibit Hall

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Supported By

Wednesday, Sep 18th

3:00 PM – 3:30 PM PDT

RAPS Fellows: How to Maximize the Application Process

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Exhibit Hall: RAPS CentralNetworking Opportunity

Wednesday, Sep 18th

3:15 PM – 4:30 PM PDT

Exclusive Exhibit Hall Hours: Networking & Presentations

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Wednesday, Sep 18th

3:30 PM – 4:30 PM PDT

RAPS Chapter/LNG Meet and Greet in Career Central

Location/Room: Exhibit Hall: Career Central (Booth 349)

Exhibit Hall: Career CentralNetworking Opportunity

Supported By

Wednesday, Sep 18th

3:45 PM – 4:15 PM PDT

RAPS BOD Roundtable: The Futuristic Regulatory Professional

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Guest Speaker: Carol M. Cooper, MS, RAC, IM(ASCP), RM(AAM) – CM Cooper & Associates

Guest Speaker: Gert W. Bos, MSc, PhD and FRAPS – Qserve Group

Guest Speaker: Lawrence E. Liberti, MSc, PhD

Guest Speaker: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

Wednesday, Sep 18th

6:00 PM – 9:00 PM PDT

Dine Arounds (Sign-up Required)

Location/Room: Offsite

Reservation RequiredNetworking Opportunity

Wednesday, Sep 18th

7:30 PM – 10:00 PM PDT

SOLD OUT Convergence Networking Party at Gaucho Beach (Separate Ticketed Event)

Location/Room: Offsite: Gaucho Beach

Separate Ticketed EventNetworking Opportunity

Thursday, Sep 19th

8:00 AM – 8:45 AM PDT

RAPS Convergence 2024 Plenary Session: Modern Challenges and Opportunities Within the Workspace

Location/Room: Level 2: Grand Ballroom

Moderator: Chris Whalley – Pfizer

Panelist: Harshit R. Bhoraniya, MS – Northeastern University

Panelist: Kathryn Blank – Becton Dickinson

Panelist: Tyler Trinh – University of Houston College of Pharmacy

Networking Opportunity

Thursday, Sep 19th

8:00 AM – 5:00 PM PDT

RAPS Wellness Challenge

Location/Room: Main Lobby (Tech Support Desk Area)

Networking Opportunity

Thursday, Sep 19th

8:45 AM – 9:00 AM PDT

Convergence 2024 Reflections and Preview of 2025

Location/Room: Level 2: Grand Ballroom

Speaker: Jethro Ekuta, DVM, PhD, RAC, FRAPS – Alexion, AstraZeneca Rare Disease

Speaker: Gert W. Bos, MSc, PhD and FRAPS – Qserve Group

Networking Opportunity

Thursday, Sep 19th

10:30 AM – 1:00 PM PDT

Exclusive Exhibit Hall Hours: Networking & Presentations

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Thursday, Sep 19th

10:30 AM – 3:30 PM PDT

Exhibit Hall Open

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Thursday, Sep 19th

10:45 AM – 11:15 AM PDT

RAPS BOD Roundtable: Volunteering

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Guest Speaker: Patricia Castro – Abbott

Guest Speaker: Jocelyn Jennings, MS, RAC, FRAPS – Mycovia Pharmaceuticals, Inc.

Guest Speaker: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

Thursday, Sep 19th

11:30 AM – 12:00 PM PDT

RAPS BOD Roundtable: The Futuristic Regulatory Professional

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Guest Speaker: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho

Guest Speaker: Kimberly A. Trautman, MS – RAPS BoD

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

Thursday, Sep 19th

11:30 AM – 12:30 PM PDT

RAPS “Speed Mentoring” in Career Central

Location/Room: Exhibit Hall: Career Central (Booth 349)

Exhibit Hall: Career CentralNetworking Opportunity

Supported By

Thursday, Sep 19th

11:30 AM – 1:00 PM PDT

Networking Lunch in the Exhibit Hall

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Thursday, Sep 19th

2:00 PM – 2:30 PM PDT

Refreshment Break in the Exhibit Hall

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Supported by

Thursday, Sep 19th

2:00 PM – 3:15 PM PDT

Exclusive Exhibit Hall Hours: Networking & Presentations

Location/Room: Exhibit Hall

Networking OpportunityExhibit Hall

Thursday, Sep 19th

2:30 PM – 3:00 PM PDT

RAPS BOD Roundtable: I Am Regulatory

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Guest Speaker: Jocelyn Jennings, MS, RAC, FRAPS – Mycovia Pharmaceuticals, Inc.

Guest Speaker: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

Thursday, Sep 19th

6:00 PM – 9:00 PM PDT

SOLD OUT (Advanced Sign-Up Required) RAPS Convergence 2024: Under the Sea Closing Party

Location/Room: The Cove

Networking OpportunityReservation Required

Supported by

Other

Monday, Sep 16th

8:30 AM – 4:00 PM PDT

Communicating with Agency Officials, Top Management, and Other Stakeholders for Gaining Alignment on Strategic Initiatives

Location/Room: 201

Presenter: Richard J. DeRisio, MS – DeRisio Group, LLC

Workshop Leader: Nancy Singer, JD, LLM, RAC, FRAPS – Compliance-Alliance, LLC

Presenter: Rosanne M. Melikian, PhD, MSRS, RAC – Johnson & Johnson MedTech, Vision

Preconference WorkshopOther

Wednesday, Sep 18th

10:35 AM – 11:05 AM PDT

Solution Circle (C): Leveraging Dual RAC Certification to become an Expert in Enhancing the Success of Combination Product Development.

Location/Room: Exhibit Hall: Solutions Circles Area (C)

Facilitator: Charles Nnabuife, B.Pharm, MBA, RAC-Drugs – Veristat Inc

Exhibit Hall: Solutions CircleOther

Wednesday, Sep 18th

11:45 AM – 12:15 PM PDT

Solution Circle (A): Career Pathways in Regulatory Affairs

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Jay Patel, MS – KPMG

Exhibit Hall: Solutions CircleOther

Thursday, Sep 19th

10:35 AM – 11:05 AM PDT

Solution Circle (A): How to Break Through the Regulatory Glass Ceiling and Get Hired!

Location/Room: Exhibit Hall: Solutions Circles Area (A)

Facilitator: Ritam Priya, BA, MBA – Novarum MDRQ Consulting

Exhibit Hall: Solutions CircleOther

Thursday, Sep 19th

11:10 AM – 11:40 AM PDT

Solution Circle (B): Diversity in Clinical Trials

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Anagha Shende, MBBS, MD – Lexicon Pharmaceuticals Inc.

Exhibit Hall: Solutions CircleOther

Thursday, Sep 19th

2:30 PM – 3:00 PM PDT

Solution Circle (B): Taking your Skills to the Next Level: Transform your Career

Location/Room: Exhibit Hall: Solutions Circles Area (B)

Facilitator: Kiran Gulati, MBA, Exemplar Lead Auditor – UCSC Silicon Valley Extension

Exhibit Hall: Solutions CircleOther

Preconference Workshop

Monday, Sep 16th

8:30 AM – 4:00 PM PDT

Advanced Leadership Workshop (Day 1 of 2)

Location/Room: 101

Workshop Leader: Trista Schoonmaker, PCC – COPIA Leadership

Preconference WorkshopSkill Building

Monday, Sep 16th

8:30 AM – 4:00 PM PDT

Artificial Intelligence knocking on your door? The upcoming Artificial Intelligence Act’s Technical Documentation Requirements and how to integrate them into a Medical Device Regulation Submission

Location/Room: 102

Workshop Leader: Sarah Mathew – BSI

Presenter: Daniela Seneca, MEng – BSI

Presenter: Kenneth Fuh, PhD – TÜV SÜD Product Service GmbH

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

Monday, Sep 16th

8:30 AM – 4:00 PM PDT

Communicating with Agency Officials, Top Management, and Other Stakeholders for Gaining Alignment on Strategic Initiatives

Location/Room: 201

Presenter: Richard J. DeRisio, MS – DeRisio Group, LLC

Workshop Leader: Nancy Singer, JD, LLM, RAC, FRAPS – Compliance-Alliance, LLC

Presenter: Rosanne M. Melikian, PhD, MSRS, RAC – Johnson & Johnson MedTech, Vision

Preconference WorkshopOther

Monday, Sep 16th

8:30 AM – 4:00 PM PDT

Drug Development in the EU: Regulatory Standards, Supports, and New Approaches

Location/Room: 104 A

Workshop Leader: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency

Presenter: Karl-Heinz Huemer – khhconsulting

Presenter: Sue Liu, B.Eng (pharm) MBA RAC – Gilead Sciences

Presenter: Daniela Drago, RAC, FRAPS – NDA Partners

Presenter: Sabine Haubenreisser, MSc, PhD – European Medicines Agency

Presenter: John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority

Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)

Monday, Sep 16th

8:30 AM – 4:00 PM PDT

Sharpening Your Regulatory Soft Skills Toolbox

Location/Room: 104 C

Workshop Leader: Susan Speicher, MS, RAC – Wolters Kluwer UpToDate, Inc.

Presenter: Sue Hibbeln, MS, RAC – Lumos Diagnostics

Presenter: Bill McMoil, MBA – Regulatory Affairs Professionals Society (RAPS)

Preconference WorkshopSkill Building

Monday, Sep 16th

8:30 AM – 4:00 PM PDT

Survivor: The FDA 510(k) Program Edition (Day 1 of 2)

Location/Room: 202

Presenter: Mark E. DuVal, JD, FRAPS – DuVal & Associates, P.A.

Presenter: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.

Presenter: Kathy Herzog, BSME – DuVal & Associates, P.A.

Presenter: Allison Komiyama, PhD, RAC, FRAPS – RQM+

Presenter: Dongbo Wang, PhD – Histosonics

Presenter (Remote): Ken Skodacek – FDA/CDRH

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

Tuesday, Sep 17th

8:30 AM – 4:00 PM PDT

Advanced Leadership Workshop (Day 2 of 2)

Location/Room: 101

Workshop Leader: Trista Schoonmaker, PCC – COPIA Leadership

Preconference WorkshopSkill Building

Tuesday, Sep 17th

8:30 AM – 4:00 PM PDT

Basics of Regulatory Strategy for the US & EU for Devices (includes Medical Devices and In Vitro Diagnostics)

Location/Room: 102

Workshop Leader: Ayesha Shah – Veeva Systems

Presenter: Josh Silverstein, PhD – Philips

Presenter: Sabina Hoekstra, PharmD FRAPS – TÜV SÜD Medical Health Services

Presenter (Remote): Christelle Bouygues, PharmD – EMA

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

Tuesday, Sep 17th

8:30 AM – 4:00 PM PDT

Maximizing Opportunities to Engage With the FDA

Location/Room: 104 A

Workshop Leader: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceutical, Inc.

Presenter: Angela W. Corona, PhD – BOLDAPPROVALS

Presenter: Christy Cottrell – FDA/CDER

Presenter: Ramani Sista, PhD – ORMRR/OTP/CBER/FDA

Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)

Tuesday, Sep 17th

8:30 AM – 4:00 PM PDT

MDR Surveillance, Post-Certification and Re-certification Submissions to Notified Bodies: Best Practice for Manufacturers

Location/Room: 104 B

Workshop Leader: Purvi S. Patel, PhD CEng – BSI

Presenter: Rachel Mead, BEng MIET – BSI

Presenter: Vishal Thakker, MEng – BSI

Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS

Presenter: Duncan McPherson, MBBS FRCA – LNE-GMED-UK

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

Tuesday, Sep 17th

8:30 AM – 4:00 PM PDT

Strategy and Regulatory Intelligence (RI) Primer: How to Construct and Maintain it Using AI Tools

Location/Room: 104 C

Presenter: Meredith Brown-Tuttle, FRAPS – Regulatorium

Presenter: Jay H. Mashburn, PhD, RPh – Recursion Pharmaceuticals, Inc.

Preconference WorkshopSkill Building

Tuesday, Sep 17th

8:30 AM – 4:00 PM PDT

Survivor: The FDA 510(k) Program Edition (Day 2 of 2)

Location/Room: 202

Presenter: Mark E. DuVal, JD, FRAPS – DuVal & Associates, P.A.

Presenter: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.

Presenter: Kathy Herzog, BSME – DuVal & Associates, P.A.

Presenter: Allison Komiyama, PhD, RAC, FRAPS – RQM+

Presenter: Dongbo Wang, PhD – Histosonics

Presenter (Remote): Ken Skodacek – FDA/CDRH

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

Preconference Workshops Only

Monday, Sep 16th

7:30 AM – 8:30 AM PDT

Networking Breakfast & Welcome for Preconference Workshops Registrants (Workshop Registrants Only)

Location/Room: Main Lobby (Near Room 104)

Preconference Workshops Only

Monday, Sep 16th

10:30 AM – 11:00 AM PDT

Networking Break for Preconference Workshops Registrants (Workshop Registrants Only)

Location/Room: Main Lobby Areas

Preconference Workshops Only

Monday, Sep 16th

12:30 PM – 1:30 PM PDT

Networking Lunch for Preconference Workshops Registrants (Workshop Registrants Only)

Location/Room: Main Lobby (Near Room 104)

Preconference Workshops Only

Monday, Sep 16th

3:00 PM – 3:15 PM PDT

Afternoon Break for Preconference Workshops Registrants (Workshop Registrants Only)

Location/Room: Main Lobby Areas

Preconference Workshops Only

Tuesday, Sep 17th

7:30 AM – 8:30 AM PDT

Networking Breakfast & Welcome for Preconference Workshops Registrants (Workshop Registrants Only)

Location/Room: Main Lobby (Near Room 104)

Facilitator: Patrick Flynn – RAPS

Preconference Workshops Only

Tuesday, Sep 17th

10:30 AM – 11:00 AM PDT

Networking Break for Preconference Workshops Registrants (Workshop Registrants Only)

Location/Room: Main Lobby Areas

Preconference Workshops Only

Tuesday, Sep 17th

12:30 PM – 1:30 PM PDT

Networking Lunch for Preconference Workshops Registrants (Workshop Registrants Only)

Location/Room: Main Lobby (Near Room 104)

Preconference Workshops Only

Tuesday, Sep 17th

3:00 PM – 3:15 PM PDT

Afternoon Break for Preconference Workshops Registrants (Workshop Registrants Only)

Location/Room: Main Lobby Areas

Preconference Workshops Only

RAPS BOD Roundtable

Wednesday, Sep 18th

10:45 AM – 11:15 AM PDT

RAPS BOD Roundtable: Emerging Regulatory Trends

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Guest Speaker: Daniela Drago, RAC, FRAPS – NDA Partners

Guest Speaker: Lawrence E. Liberti, MSc, PhD

Guest Speaker: Diana Salditt, FRAPS – Salditt Regulatory Consulting LLC

Guest Speaker: Kimberly A. Trautman, MS – RAPS BoD

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

Wednesday, Sep 18th

3:45 PM – 4:15 PM PDT

RAPS BOD Roundtable: The Futuristic Regulatory Professional

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Guest Speaker: Carol M. Cooper, MS, RAC, IM(ASCP), RM(AAM) – CM Cooper & Associates

Guest Speaker: Gert W. Bos, MSc, PhD and FRAPS – Qserve Group

Guest Speaker: Lawrence E. Liberti, MSc, PhD

Guest Speaker: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

Thursday, Sep 19th

10:45 AM – 11:15 AM PDT

RAPS BOD Roundtable: Volunteering

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Guest Speaker: Patricia Castro – Abbott

Guest Speaker: Jocelyn Jennings, MS, RAC, FRAPS – Mycovia Pharmaceuticals, Inc.

Guest Speaker: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

Thursday, Sep 19th

11:30 AM – 12:00 PM PDT

RAPS BOD Roundtable: The Futuristic Regulatory Professional

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Guest Speaker: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho

Guest Speaker: Kimberly A. Trautman, MS – RAPS BoD

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

Thursday, Sep 19th

2:30 PM – 3:00 PM PDT

RAPS BOD Roundtable: I Am Regulatory

Location/Room: Exhibit Hall: RAPS Central (Booth 813)

Guest Speaker: Jocelyn Jennings, MS, RAC, FRAPS – Mycovia Pharmaceuticals, Inc.

Guest Speaker: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

Reservation Required

Wednesday, Sep 18th

6:00 PM – 9:00 PM PDT

Dine Arounds (Sign-up Required)

Location/Room: Offsite

Reservation RequiredNetworking Opportunity

Thursday, Sep 19th

6:00 PM – 9:00 PM PDT

SOLD OUT (Advanced Sign-Up Required) RAPS Convergence 2024: Under the Sea Closing Party

Location/Room: The Cove

Networking OpportunityReservation Required

Supported by

Separate Ticketed Event

Wednesday, Sep 18th

5:45 PM – 7:15 PM PDT

Honoring Excellence: RAPS 2024 Awards Celebration (Invitation Only)

Location/Room: Offsite: Hyatt Regency Beacon Ballroom

Separate Ticketed Event

Wednesday, Sep 18th

7:30 PM – 10:00 PM PDT

SOLD OUT Convergence Networking Party at Gaucho Beach (Separate Ticketed Event)

Location/Room: Offsite: Gaucho Beach

Separate Ticketed EventNetworking Opportunity

Skill Building

Monday, Sep 16th

8:30 AM – 4:00 PM PDT

Advanced Leadership Workshop (Day 1 of 2)

Location/Room: 101

Workshop Leader: Trista Schoonmaker, PCC – COPIA Leadership

Preconference WorkshopSkill Building

Monday, Sep 16th

8:30 AM – 4:00 PM PDT

Sharpening Your Regulatory Soft Skills Toolbox

Location/Room: 104 C

Workshop Leader: Susan Speicher, MS, RAC – Wolters Kluwer UpToDate, Inc.

Presenter: Sue Hibbeln, MS, RAC – Lumos Diagnostics

Presenter: Bill McMoil, MBA – Regulatory Affairs Professionals Society (RAPS)

Preconference WorkshopSkill Building

Tuesday, Sep 17th

8:30 AM – 4:00 PM PDT

Advanced Leadership Workshop (Day 2 of 2)

Location/Room: 101

Workshop Leader: Trista Schoonmaker, PCC – COPIA Leadership

Preconference WorkshopSkill Building

Tuesday, Sep 17th

8:30 AM – 4:00 PM PDT

Strategy and Regulatory Intelligence (RI) Primer: How to Construct and Maintain it Using AI Tools

Location/Room: 104 C

Presenter: Meredith Brown-Tuttle, FRAPS – Regulatorium

Presenter: Jay H. Mashburn, PhD, RPh – Recursion Pharmaceuticals, Inc.

Preconference WorkshopSkill Building

Wednesday, Sep 18th

9:15 AM – 10:30 AM PDT

Progress Towards Unlocking Opportunities for Entry-Level Positions in Regulatory Affairs

Location/Room: 104 B

Session Leader: Jethro Ekuta, DVM, PhD, RAC, FRAPS – Alexion, AstraZeneca Rare Disease

Presenter: Brian Savoie – Regulatory Affairs Professionals Society (RAPS)

Presenter: Ritu Dhami – Network Partners Group (NPG)

Presenter: Grace Gowda, M.Pharm., PhD, RAC – University of Georgia

Presenter: Parminder Kalle, BSc (Hons), Dip Prof Skills – Elemed

Presenter: Neelu Gibson – Becton, Dickinson & Company (BD)

Skill Building

Wednesday, Sep 18th

2:15 PM – 3:15 PM PDT

Nurturing a Regulatory Excellence Ecosystem: Cultivating the Culture of Regulatory Affairs in Early Career Professionals

Location/Room: 104 B

Moderator: Amra Racic – Veeva Systems

Presenter: Harshit R. Bhoraniya, MS – Northeastern University

Presenter: Griffin Riggs, MS – Alphatec Spine

Presenter: Kurtis Hunsberger, RAC – Bracco Medical Technologies

Skill Building

Wednesday, Sep 18th

4:30 PM – 5:30 PM PDT

Dive Deep: Navigating the Regulatory Maze of Concurrent Regulatory Submissions

Location/Room: 104 B

Moderator: Stacy Townsend, PhD, PMP, SSM – Integrated Project Management

Moderator: Vidya Narayanaswamy, MS, MBA, PMP, SSM – Integrated Project Management

Presenter: Celina Pettersen, MS – Entrada Therapeutics

Presenter: Cassandra T. San Jose, MS, RAC, PMP, SCPM – Biogen

Presenter: Meriem Gaval Cruz, PhD, RAC – Novo Nordisk

Skill Building

Thursday, Sep 19th

9:15 AM – 10:30 AM PDT

Dangerous Documents: Avoiding Landmines in Your Records and Emails

Location/Room: 104 B

Session Leader: Nancy Singer, JD, LLM, RAC, FRAPS – Compliance-Alliance, LLC

Presenter: Susan Speicher, MS, RAC – Wolters Kluwer UpToDate, Inc.

Presenter: Laura I. Ballesteros – Hologic Inc.

Presenter: Elizabeth Nguyen-Espinoza, MA – OptimaPath Inc.

Skill Building

Thursday, Sep 19th

1:00 PM – 2:00 PM PDT

Finding a Job in Regulatory Affairs or Regulatory Compliance: Skills for Success

Location/Room: 104 A

Session Leader: Kiran Gulati, MBA, Exemplar Lead Auditor – UCSC Silicon Valley Extension

Presenter: Jay Vaishnav, PhD, RAC-Devices, FRAPS – Canon Medical Informatics, Inc.

Presenter (Remote): Kristen Grumet – ELIQUENT

Presenter (Remote): Catherine A. Olguin, PhD – CDRH, Food and Drug Administration

Skill Building

Student Focus

Tuesday, Sep 17th

2:30 PM – 3:30 PM PDT

Career Development Session for Students

Location/Room: 103 C

Moderator: Kim Young, MSc – RAPS

Presenter: Sequita Lindsey, MSRA, RAC-Global, FRAPS – Lindsey Regulatory Affairs Consulting, LLC

Presenter: Parminder Kalle, BSc (Hons), Dip Prof Skills – Elemed

Presenter: Keith Morel, PhD – Qserve Group

Guest Speaker: Harshit R. Bhoraniya, MS – Northeastern University

Student Focus

Wednesday, Sep 18th

10:30 AM – 4:30 PM PDT

Student Capstone Poster Display: Benchmarking drug regulatory systems for capacity building in registration and marketing authorization: a systematic review

Location/Room: Exhibit Hall: Career Central (Booth 349)

Graduate Student Presenter: Junnan Shi

Student Focus

Wednesday, Sep 18th

10:30 AM – 4:30 PM PDT

Student Capstone Poster Display: Comparative Analysis of Orphan Drug Legislation: USA, EU, and India Perspectives

Location/Room: Exhibit Hall: Career Central (Booth 349)

Graduate Student Presenter: Kunal Sharma

Student Focus

Wednesday, Sep 18th

10:30 AM – 4:30 PM PDT

Student Capstone Poster Display: E-Labeling Essentials: Adapting Processes to Meet Evolving Global Standards and Regulations

Location/Room: Exhibit Hall: Career Central (Booth 349)

Graduate Student Presenter: Nishitha CHERUKURI, MS – NORTHEASTERN UNIVERSITY

Student Focus

Wednesday, Sep 18th

10:30 AM – 4:30 PM PDT

Student Capstone Poster Display: Opportunities of Patient-Centered Approaches in Clinical Study Design

Location/Room: Exhibit Hall: Career Central (Booth 349)

Graduate Student Presenter: Sunny Hsu

Student Focus

Thursday, Sep 19th

10:30 AM – 3:30 PM PDT

Student Capstone Poster Display: Benchmarking drug regulatory systems for capacity building in registration and marketing authorization: a systematic review

Location/Room: Exhibit Hall: Career Central (Booth 349)

Graduate Student Presenter: Junnan Shi

Student Focus

Thursday, Sep 19th

10:30 AM – 3:30 PM PDT

Student Capstone Poster Display: Comparative Analysis of Orphan Drug Legislation: USA, EU, and India Perspectives

Location/Room: Exhibit Hall: Career Central (Booth 349)

Graduate Student Presenter: Kunal Sharma

Student Focus

Thursday, Sep 19th

10:30 AM – 3:30 PM PDT

Student Capstone Poster Display: E-Labeling Essentials: Adapting Processes to Meet Evolving Global Standards and Regulations

Location/Room: Exhibit Hall: Career Central (Booth 349)

Graduate Student Presenter: Nishitha CHERUKURI, MS – NORTHEASTERN UNIVERSITY

Student Focus

Thursday, Sep 19th

10:30 AM – 3:30 PM PDT

Student Capstone Poster Display: Opportunities of Patient-Centered Approaches in Clinical Study Design

Location/Room: Exhibit Hall: Career Central (Booth 349)

Graduate Student Presenter: Sunny Hsu

Student Focus

Thursday, Sep 19th

11:30 AM – 12:00 PM PDT

Career Central Stage: Opportunities for Professionals & Students of Graduate Regulatory Education

Location/Room: Exhibit Hall: Career Central (Booth 349)

Presenter: Susan Bain, DRSc, MSc, DRSc – University of Southern California

Presenter: Emil Wang – U.S. Public Health Service

Student FocusExhibit Hall: Career Central

Supported By

Thursday, Sep 19th

12:15 PM – 12:25 PM PDT

Career Central Stage: Student Capstone Presentation: Global MedRegs (Global Regulatory Requirements for Medical Devices) "Simplifying your Regulatory Journey Across International Markets”

Location/Room: Exhibit Hall: Career Central (Booth 349)

Graduate Student Presenter: Akash Kirani Adarshakumar, n/a – NORTHEASTERN UNIVERSITY

Student FocusExhibit Hall: Career Central

Supported By