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. Obtain up-to-date information on program progress and current initiatives and journey with us through a high-level regulatory overview of the complete ANDA review pathway!
- Attend either on-site at the DoubleTree Hotel, Silver Spring, MD or virtually online –
- This event is FREE -
- Pre-approved by RAPS as eligible for up to 12 credits towards RAC recertification -
- NETWORKING opportunities available -
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!
Office of Pharmaceutical Quality (OPQ) Update
GDUFA II
Pre-filing policy issues
Clinical Bioequivalence and many more!
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
This is a MUST ATTEND event for all professionals involved with the generic drug industry!
For more information on
CDER SBIA
(866)-405-5367 | (301)-796-6707 | CDERSBIA@fda.hhs.gov
CDER SBIA Learn
GDUFA
CDER SBIA
(866)-405-5367 | (301)-796-6707 | CDERSBIA@fda.hhs.gov
CDER SBIA Learn
GDUFA
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