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AGENDA

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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

• FDA Office of Generic Drugs Global Generic Drug Affairs
• FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

• RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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• Please contact [email protected] for all technical questions.
• If you encounter any technical issues before or during the event, please visit the Technical Issues Support
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