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  4. Expanding Generic Drug Access Through International Engagements - 02/28/2024
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Virtual | Virtual

Event Title
Expanding Generic Drug Access Through International Engagements
February 28, 2024


Date:
February 28, 2024
Time:
9:00 AM - 11:30 AM ET

Topics & Presentations

Speakers

Expanding Generic Drug Access Through International Engagements

 

Unlocking Global Access to Generic drugs

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

FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Drug Products

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

International Engagement with OGD Parallel Scientific Advice (PSA) Process

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

EMA and International Engagement for Generics Development

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

Use of Foreign Comparators in Bioequivalence Studies for Health Canada

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)

Discussion Panel

Sarah Ibrahim, Kevin Blake, Scott Appleton,

and

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

Presenter Q&A Discussion Panel

Sarah Ibrahim, Lei K. Zhang, Caliope Sarago, Kevin Blake, and Scott Appleton

Closing Remarks

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

 

AGENDA

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS WEBINAR

FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs. One of the ways OGD supports generic drug regulatory activities is through international engagements.

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

INTENDED AUDIENCE

  • Members of global regulatory agencies including regulatory reviewers
  • Generic drug industry including current and prospective applicants who are interested in submitting an application for a generic drug
  • Consultants focused on bioequivalence, and clinical research coordinators

TOPICS COVERED

  • FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generics/Hybrid Products
  • Generic Drug Cluster
  • International Collaboration Among Regulatory Agencies

AGENDA

FDA RESOURCES

 
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