SBIA Webinar | FDA-EMA Parallel Scientific Advice (PSA) Program

Registration is now open!

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance WEBINARS FDA-EMA Parallel Scientific Advice (PSA) Program Registration 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 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 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 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: 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. has been 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. has been 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. has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material. The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter

This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.   SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA