SBIA Education Events

Supporting Events from FDA CDER Small Business & Industry Assistance


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Generic Drugs Forum 2021:
Lifecycle of a Generic Drug
April 28 & 29, 2021

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This event is FREE

Via Webcast

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.

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Full Agenda Coming Soon

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.

This Workshop:

  • 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.

Agenda & Speaker Bios

PDF Download
Event Agenda

The agenda is currently under development and will be linedk here when it is ready.

PDF Download
Speaker Biographies

The speaker biographies document is being finalized and will be posted here as soon as it is ready.

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Virtual Attendance Information

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.

Last Name A – K

Last Name L – Z

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:

https://concerted.adobeconnect.com/common/help/en/support/meeting_test.htm

Files, Certificate & Recordings

ZIP of Day One Session Slides

ZIP of Day Two Session Slides

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.

Session Recordings:

Links to recordings will be added as they become available.

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Questions & More Information

Questions?

Please refer the FAQs page on this website. If you are not able to find your answer there, please email us at info@sbiaevents.com.

More Information

If you have questions regarding the content of the event or other CDER-specific information, please: