Generic Drugs Forum 2021:
Lifecycle of a Generic Drug
April 28 & 29, 2021
This event is FREE
This event offers practical advice, case studies, and a deep dive into the Abbreviated New Drug Application (ANDA) review process. Presentations will focus on various aspects from pre-ANDA, drug development, post-marketing and global generic drug affairs program support for the generic drug program.
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
- prepare regulatory submissions
Continuing Education Credit
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.
- has been pre-approved by RAPS as eligible for credits (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 agenda may be updated as changes are made. The link above is to the latest version, Version 6, updated on April 13, 2021.
The speaker biographies document is being finalized and will be posted 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 below within 24 hours.
The links below to the Adobe Connect rooms will be activated shortly before the event begins.
Please select the correct room based on the first letter of your LAST NAME.
The above rooms will open ~15 minutes before each day begins.
If you encounter any technical issues, visit the Technical Issues Support Page
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.
Link to Final Evaluation & Certificate of Attendance
The above link will become active at the conclusion of the event.
Links to recordings will be added as they become available.
If you have questions regarding the content of the event or other CDER-specific information, please: