Generic Drugs Forum
April 15 & 16, 2020
This event is FREE to attend
Virtual Online Attendance Only
This event offers practical advice, case studies, and a deep dive into the Abbreviated New Drug Application (ANDA) assessment process. FDA will also discuss science unique to generic drug applications.
Sally Choe, PhD
Michael Kopcha, PhD, RPh
- Product Specific Guidances (PSGs)
- Generic Drug Labeling: Recommendations for High-Quality Submissions
- New Programs and Requirements Under FDARA
- Pre-ANDA Interactions with the FDA
- The Importance of Generic Drug Pharmacovigilance
- And much more…
Who Should Attend?
The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who:
- Plan to submit an ANDA or are in the process of submitting an ANDA
- Involved in generic drug development
- Work on bioequivalence, stability, dissolution and impurity testing
- Submit Drug Master Files (DMFs)
- Prepare regulatory submissions
Continuing Education Credit
- has been pre-approved by RAPS as eligible for credits towards a participant’s RAC recertification upon full completion
- is eligible for SOCRA credit 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. Candidate must provide documentation of participation.
- 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.
- is approved for ACRP research-specific continuing education at the completion of this activity. Contact hours are provided at 1 point/hour for at least 45-60 minutes of qualified material.
- Real-time attendance is required for attendance certificates which are only available during the two weeks after the event.
The agenda is subject to change. Updated versions will be linked here as they become available. The current version is version 8, updated on March 29, 2020.
This PDF file contains brief biographies of the FDA speakers participating in the conference. The biographies document is still under development and will be linked here as soon as it is ready.
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.
If you encounter any technical issues, visit the Technical Issues Support Page
The above rooms will open 15 minutes before each day begins.
Randomly pick whichever Room you prefer. Please do not join both rooms at the same time.
The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.
To test your PC, please visit:
The ZIP files above will be available for download 24 hours before the event.
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: