Drugs

CDER Small Business and Industry Assistance (SBIA) Regulatory Education for Industry (REdI): Generic Drugs Forum April 4-5, 2017

Image of CDER SBIA April 2017 REdI

 

Presentation Slides and Recordingsdisclaimer icon                        This Event is FREE                                 AGENDAdisclaimer icon

 

You are invited to the Regulatory Education for Industry (REdI): Generic Drugs Forum 2017.

This two-day FDA-led forum offers you the opportunity to interact with FDA subject matter experts from across CDER involved in the Generic Drug Review Program. You will:

  • Obtain up-to-date information on program progress and current initiatives.
  • Journey with us through a high-level regulatory overview of the complete ANDA review pathway.

Keynote Speaker: Kathleen Uhl, M.D.  Director, Office of Generic Drugs | CDER | FDA

Discussions include:

  • Office of Generic Drugs (OGD) Regulatory Science Update
  • Office of Pharmaceutical Quality (OPQ) Update
  • GDUFA II
  • Pre-filing policy issues
  • Clinical Bioequivalence and many more.

This is a MUST ATTEND event for all professionals involved with the generic drug industry.
 

Advance registration is required.
When you register, you may choose to attend either on-site at the DoubleTree Hotel, Silver Spring, MD or virtually online via Adobe Connect. We ask that you please honor your registration commitment to help us plan this conference efficiently. If you need to change your registration, please email us at cancelation@SBIAevents.com

Take advantage of NETWORKING opportunities during lunch breaks so you can grow your influence and expand your connections. Another networking opportunity is after the conference on April 4. All networking events will be held in the hotel’s Savor Restaurant. These are optional self-pay events, and reservations are not necessary. Food and drinks will be available for purchase on own.

Continuing Education Credits
This 2 day conference has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification.

 

For more information on
CDER SBIA
(866)-405-5367 | (301)-796-6707 | CDER Small Business and Industry Assistance

CDER SBIA Learn
GDUFA

 
 
 
 
 

 

Page Last Updated: 04/07/2017
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