---

---

---

Visit CDER Small Business and Industry Assistance Page

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

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:

• approved for 1.5 contact hours of continuing education for pharmacists, physicians and nurses. Please see detailed announcement for more information.
• 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.
• pre-approved by 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.
• pre-approved by 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.
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

• To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
• 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.
• Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.