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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.

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

SPEAKERS

Parallel Scientific Advice 101: Purpose, Process, Timelines
Anabela Marçal
EMA Liaison Official at U.S. Food and Drug Administration
International Affairs Division
European Medicines Agency (EMA)

Results of Five Year PSA Program Review
Shannon Thor, PharmD, MS
Lieutenant Commander, US Public Health Service
International Policy Analyst | Europe Office
Office of Global Policy and Strategy (OGPS)
Office of the Commissioner (OC)
U.S. Food and Drug Administration

PSA Case Studies
Thorsten Vetter, M.D.
Clinical Pharmacologist
Senior Scientific Officer
Scientific Advice Office
European Medicines Agency (EMA)

PSA Best Practices for Sponsors
Sandra L. Kweder, M.D.
Deputy Director | Europe Office
FDA Liaison to the European Medicines Agency
Office of Global Policy and Strategy (OGPS)
U.S. Consulate, Amsterdam, NL
U.S. Food and Drug Administration

FDA RESOURCES

• FDA link for General Principles EMA-FDA Parallel Scientific Advice (Human Medicinal Products)
• EMA link for General Principles EMA-FDA Parallel Scientific Advice (Human Medicinal Products)
• European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance