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 March 2, 2022
Dear International Colleague,
You are invited to participate in this upcoming webinar on the FDA-EMA Parallel Scientific Advice (PSA) Program. It features two staffers from the Office of Global Policy and Strategy’s Europe Office, LCDR Shannon Thor and Dr. Sandra Kweder. Please see the information below to register.
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FDA-EMA Parallel Scientific Advice (PSA) Program
ABOUT THIS WEBINAR
As medicines development continues towards a globalized approach, both the pharmaceutical industry and regulatory agencies increasingly seek opportunities to proactively engage early in product development. The Parallel Scientific Advice (PSA) program shared by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) provides a mechanism for experts to concurrently engage in scientific discourse with sponsors on key issues during the development phase of new medicinal products (drugs, biologicals, vaccines, advanced therapies). In 2022, scientists overseeing PSA at EMA and FDA conducted a 5-year program review. This webinar shares insights from the 5-year review and describes best practices for companies considering PSA.
FDA RESOURCES
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TOPICS COVERED
- FDA will provide an overview of the Parallel Scientific Advice (PSA) program. Participants will gain a general understanding including how to submit a PSA request, the expected procedure timeline and outcomes.
- FDA will present findings from a 5-year PSA program review.
- FDA will offer best practice recommendations for those considering a PSA request.
INTENDED AUDIENCE
- Regulatory affairs professionals and researchers working on global product development programs
- Foreign regulators
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