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          FDA-EMA Parallel Scientific Advice (PSA) Program - 03/16/2022News & Events for Human Drugs Webcast
    Event Title
              FDA-EMA Parallel Scientific Advice (PSA) Program


                  March 16, 2022

  

    
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      Meeting Information
                Event MaterialsDate:
          
  


     
           

March 16, 2022   

 
 
        
                                      Time: 
                                      
10:00 AM
    - 11:30 AM
ET

 

  Visit CDER Small Business and Industry Assistance Page



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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 regulatorsSPEAKERS

**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


Event Materials

  Title
            File Type/SizeConsidering a PSA Request Summary and Best Practices FDA-EMA Parallel Scientific Advice PSA Program March 16, 2022
              pdf               (3.50 MB)

                                                                                  Content current as of:
      01/24/2023
         
                   
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