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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.
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)
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)