Note: The annual FREE FDA CDER SBIA Complex Generic Drug Product Development Workshop has been renamed to:
Advancing Innovative Science in Generic Drug Development Workshop
September 29 & 30, 2020
This event is FREE to attend
Virtual Online Attendance Only
The goal of this science-focused workshop is to help the generic industry pave a clear scientific pathway for generic drug development. We will focus on common scientific issues seen in Abbreviated New Drug Applications (ANDAs), commonly known as generic drug applications. We will link GDUFA science and research on complex products and complex scientific issues to product-specific guidance development, discuss pre-ANDA meetings and assessment, and examine various areas of the science behind generic drug development.
- Method Development / Validations for Non-traditional Analytical Methods
- Excipient and Formulation Considerations
- Future Directions, Emerging Technology, and Current Thinking on Alternative Bioequivalence (BE) Approaches
- Practical Considerations in the Study Design and Data Evaluation Recommended in Product-Specific Guidances (PSGs)
Who Should Attend?
This event is intended for scientists, researchers, and regulatory affairs professionals who work on or are interested in working on the development of generic drugs.
Continuing Education Credit
- has been pre-approved by RAPS as eligible for up to 12 credits 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 0.25 non-GCP or non-GLP units 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.
- Continuing education certificates are available only for those who attend real-time. There is a three week deadline to obtain the certificate of attendance and complete the event survey.
The agenda may be updated. The current version is Version 14, updated September 26, 2020.
The speaker biographies document provides details on the event speakers and panelists.
The virtual conference will be hosted via Adobe Connect and is limited to 2,000 simultaneous attendees (1,000 each in Room One and Room Two). If a room is full when you attempt to enter, please try the other room. The recordings of each of the sessions will be posted on the Past Events page within 24 hours.
The links below to the Adobe Connect room for each track will be activated shortly before the event begins.
Please select the correct room based on the first letter of your LAST NAME.
The above links will become active the day of the event.
The above rooms will open ~15 minutes before each day begins.
If you encounter any technical issues, visit the Technical Issues Support Page
The above link will become active at the conclusion of the event.
If you have questions regarding the content of the event or other CDER-specific information, please: