In this webinar, FDA discussed and provided updates on FDA and EMA’s Parallel Scientific Advice (PSA) Pilot Program for complex generics/hybrid products, addressed currently available international engagement opportunities, hosted a panel discussion on topics pertinent to the generic drug industry, and answered questions during live Q&A sessions with FDA and other global regulatory experts.

Timestamps

01:25 – Unlocking Global Access to Generic drugs

19:11 – FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Drug Products

38:43 – International Engagement with OGD Parallel Scientific Advice (PSA) Process

52:10 – EMA and International Engagement for Generics Development

01:04:22 – Use of Foreign Comparators in Bioequivalence Studies for Health Canada

01:19:07 – Discussion Panel

01:54:15 – Presenter Q&A Discussion Panel

02:21:17 – Closing Remarks

Speakers | Panelists:

Sarah Ibrahim, PhD
Associate Director for Global Affairs
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER) | FDA

Lei K. Zhang, PhD
Deputy Director
Office of Research and Standards (ORS)
OGD | CDER | FDA

Caliope Sarago, MS
Team Lead (Acting) Senior Regulatory Health Project Manager
ORS | OGD | CDER | FDA

Kevin Blake, MD, PhD
Senior Scientific Specialist Clinical Pharmacology
European Medicines Agency (EMA)

Scott Appleton, PhD, MSc
Manager
Division of Biopharmaceutics Evaluation 1
Bureau of Pharmaceutical Sciences
Pharmaceutical Drugs Directorate
Health Products and Food Brach | Health Canada (HC)

Lisa Bercu, JD
Senior Regulatory Counsel
Office of Generic Drug Policy (OGDP)
OGD | CDER | FDA

Ashley Boam, MSBE
Director
Office of Policy for Pharmaceutical Quality (OPPQ)
Office of Pharmaceutical Quality (OPQ)
CDER | FDA

Robert Lionberger, PhD
Director
ORS | OGD | CDER | FDA

Hongling Zhang, PhD
Director
Division of Bioequivalence II (DBII)
Office of Bioequivalence (OB)
OGD | CDER | FDA

Iilun Murphy, MD
Director
OB | OGD | CDER) | FDA

Learn more at: https://www.fda.gov/drugs/news-events...

-----------------------

FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Upcoming Training - https://www.fda.gov/cdersbia
SBIA Listserv - https://public.govdelivery.com/accoun...
SBIA 2022 Playlist -    • 2022 CDER Small Business and Industry...  
SBIA LinkedIn -   / cder-small-business-and-industry-assistance  
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter -   / fda_drug_info  
Email - [email protected]
Phone - (301) 796-6707 I (866) 405-5367