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Mon, Sep 14
Tue, Sep 15
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Monday, September 14, 2026
7:00 AM - 4:00 PM
EDT
Registration Hours
7:00 AM - 4:00 PM
EDT
Registration Hours
7:00 AM - 4:30 PM
EDT
Speaker Ready Room Hours
7:00 AM - 4:30 PM
EDT
Speaker Ready Room Hours
7:30 AM - 8:30 AM
EDT
Preconference Workshop Networking Breakfast & Welcome
7:30 AM - 8:30 AM
EDT
Preconference Workshop Networking Breakfast & Welcome
8:30 AM - 4:00 PM
EDT
Behind the Curtain: A Practitioner's Field Guide to Global Health Authority Transparency for Drugs and Biologics
8:30 AM - 4:00 PM
EDT
Preconference Workshop: Behind the Curtain: A Practitioner's Field Guide to Global Health Authority Transparency for Drugs and Biologics
Workshop Leader:
Linda F. Bowen, RAC US, RAC EU, RAC CDN, FRAPS
– Temple University School of Pharmacy
Workshop Presenter:
Chris J. Whalley, n/a
– Pfizer
Pharmaceuticals (includes Biologics and Drugs)
8:30 AM - 4:00 PM
EDT
Drug Development in the EU: Regulatory Standards, Revisions in Legislation, and Support Activities
8:30 AM - 4:00 PM
EDT
Preconference Workshop: Drug Development in the EU: Regulatory Standards, Revisions in Legislation, and Support Activities
Workshop Leader:
Andrea Laslop, MD (she/her/hers)
– Malta Medicines Authority
Workshop Presenter:
Karl-Heinz Huemer, PhD MD (he/him/his)
– khhconsult
Workshop Presenter:
John Borg, Prof, PhD, Technical Director, Medicines Authority Malta (he/him/his)
– Malta Medicines Authority
Workshop Presenter:
María Concepción Prieto Yerro, MD, PhD (she/her/hers)
– Malta Medicines Authority
Workshop Presenter:
Sabine Haubenreisser, MSc, PhD, FRAPS (she/her/hers)
– European Medicines Agency
Workshop Presenter:
Daniela Drago, PhD, RAC, FRAPS
– NDA Partners
Workshop Presenter:
Sue Liu, B.Eng (pharm) MBA RAC
– Gilead Sciences
Pharmaceuticals (includes Biologics and Drugs)
8:30 AM - 4:00 PM
EDT
Preconference Workshop: Briefing Books that Work: A Storyboarding Method for Meetings, Scientific Advice, and AdComs (Day 1 of 2)
8:30 AM - 4:00 PM
EDT
Preconference Workshop: Briefing Books that Work: A Storyboarding Method for Meetings, Scientific Advice, and AdComs (Day 1 of 2)
Workshop Leader:
Sai P. Bhamidipati (she/her/hers)
– Moderna, Inc.
Workshop Presenter:
Andrea Clark, PhD
– Eldridge Writing & Consulting
Workshop Presenter:
Mwango Kashoki, MD, MPH
– Parexel International
Workshop Presenter:
Ifrah Egal (she/her/hers)
– Ultragenyx Pharmaceutical
Workshop Presenter:
Necois Penn, JD, MS
– Astrazeneca
Skill Building
8:30 AM - 4:00 PM
EDT
Preconference Workshop: Co-Development of Drugs and IVD/CDx: From Early Strategy to Commercial Success
8:30 AM - 4:00 PM
EDT
Preconference Workshop: Co-Development of Drugs and IVD/CDx: From Early Strategy to Commercial Success
Moderator/Presenter:
Xiao Michelle Meng, PhD
– OBI Pharma
Moderator/Presenter:
Claudia Dollins, PhD
– GSK
Workshop Presenter:
Amber McNair, BSc(Hons), RSci, BCMAS, mTOPRA (she/her/hers)
– IQVIA
Workshop Presenter:
Vladimir Vujovic, MPharm (he/him/his)
– IQVIA
Workshop Presenter:
Yuchao Xie, PhD (she/her/hers)
– Eli Lilly
Workshop Presenter:
T. Scott Reid, PhD, MBA
– Discovery Life Sciences
Pharmaceuticals (includes Biologics and Drugs)
8:30 AM - 4:00 PM
EDT
Survivor: The FDA 510(k) and De Novo 50Th Anniversary Program Edition (Day 1 of 2)
8:30 AM - 4:00 PM
EDT
Preconference Workshop: Survivor: The FDA 510(k) and De Novo 50Th Anniversary Program Edition (Day 1 of 2)
Moderator:
Lisa L. Pritchard, BSEEE, FRAPS
– DuVal & Associates, P.A.
Presenter:
Mark E. DuVal, J.D., FRAPS
– DuVal & Associates, P.A.
Presenter:
Allison Komiyama, PH.D., RAC, FRAPS (she/her/hers)
– DuVal & Associates
Presenter:
Dongbo Wang, PhD
– Intuitive
Medical Devices
8:30 AM - 4:00 PM
EDT
The Ins and Outs of the Commission's MDR and IVDR Targeted Revision Proposal (Day 1 of 2)
8:30 AM - 4:00 PM
EDT
Preconference Workshop: The Ins and Outs of the Commission's MDR and IVDR Targeted Revision Proposal (Day 1 of 2)
Workshop Leader:
Erik R. Vollebregt
– Axon Lawyers
Workshop Presenter:
Bassil Akra, PhD (he/him/his)
– Akra Team
Workshop Presenter:
Gert W. Bos, PhD FRAPS (he/him/his)
– QServe Group
Workshop Presenter:
Sabina L. Hoekstra, PharmD, FRAPS
– TÜV SÜD Medical Health Services
Medical Devices
12:30 PM - 1:30 PM
EDT
Preconference Workshops: Networking Lunch
12:30 PM - 1:30 PM
EDT
Preconference Workshops: Networking Lunch
