SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance


2019 CDER Prescription Drug Labeling Conference

Generic Drugs Forum
April 15 & 16, 2020

This event is FREE to attend

Virtual Online Attendance Only

UPDATED INFORMATION
(as of 3/17/2020)

This meeting will not be held in person. As this remains a dynamic situation, we will continue to assess and calibrate our approach. Where possible the agency will leverage technology to host meetings allowing for remote participation. We thank you for your patience.

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.

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Keynote Speakers:

Sally Choe

Sally Choe, PhD
Director
Office of Generic Drugs (OGD)
CDER | FDA

Michael Kopcha

Michael Kopcha, PhD, RPh
Director
Office of Pharmaceutical Quality (OPQ)
CDER | FDA

Topics Include:

  • 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…

NOTE: During this event, FDA intends to discuss application case studies on FDA’s action letter timing. If you want your case considered for discussion please email us your name, applicant name, product name, application number, submission date, date of actions, and describe your application action letter timing concern(s). All your identifying factors will be anonymized/blinded if your case is selected for use. Please email the above information and any questions to CDERSBIA@fda.hhs.gov with the subject line “Case Study Suggestion for Generic Drugs Forum”.

Download Full Agenda

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

This Forum:

  • 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.

Agenda & Speaker Bios

PDF Download
Event Agenda

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.

PDF Download
Speaker Biographies

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.

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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 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:

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

Files, Certificate & Recordings

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.


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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: