- Date:
- September 24 - 25, 2024
- Day1:
- - ET
- Day2:
- - ET
Attend In Person or Online
- Hybrid Event
- In person The Bethesdan Hotel, Tapestry Collection by Hilton
8120 Wisconsin Avenue, Bethesda, MD, 20814.
Room reservation deadline: August 23, 2024 (COB Eastern Time) or when the room block is full (whichever comes first.) - Virtual via Adobe Connect
- In person The Bethesdan Hotel, Tapestry Collection by Hilton
Visit CDER Small Business and Industry Assistance Page
ABOUT THIS MEETING (Hosted by CDER SBIA)
Join us for the 2024 Advancing Generic Drug Development Workshop! FDA experts will demonstrate the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval. Dissect complex scientific challenges in ANDAs alongside FDA experts, and gain insights into GDUFA III progress, GDUFA science and research on complex products and scientific issues to product-specific guidance development, pre-ANDA and ANDA meeting discussions. The workshop will also highlight innovative science and cutting-edge methodologies in generic drug development both within the U.S. and globally.
We're thrilled to offer this workshop in a hybrid format this year!
In-person attendees will enjoy:
- Interactive poster sessions with FDA scientists, featuring topics like guidance development, advanced analytics, and PBPK modeling
- Lively discussions and Q&A with FDA experts
Virtual attendees will have access to all presentations and panel discussions, minus the poster session.
Don't miss this unique opportunity to learn about critical aspects to improve your generic drug development!
TOPICS COVERED
- Advancement in vitro characterization methodologies
- Research to support guidance development on complex products including drug-device combination products, topical products, and inhalation products
- Spotlights on recent generic drug review and approval by the FDA
- Efforts to ensure efficient and consistent high quality generic drug development
LEARNING OBJECTIVES
- Stay current with the latest advancements in science, research, guidance development, and regulatory evaluation related to generic drug products.
- Summarize and explain the key enhancements and changes introduced in GDUFA III and their potential impact on ANDAs
- Recognize and explain how the FDA's research can be leveraged to support and inform generic drug development.
- Utilize various strategies and methodologies to facilitate efficient generic drug development
INTENDED AUDIENCE
Scientists, researchers, current and prospective generic drug applicants, and regulatory affairs professionals who work on or have an interest in the development of generic drugs, including complex generic products.
KEYNOTE SPEAKERS
- FDA Commissioner (invited)
FDA RESOURCES
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 webinar has been:
- 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 info@sbiaevents.com 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.
