lunes, 2 de marzo de 2015

Announcing the 2015 REdl: Generic Drugs Forum


Announcing the 2015 REdl: Generic Drugs Forum

You are invited to our Regulatory Education for Industry (REdI): Generic Drugs Forum which takes our previous GDUFA and You conference to a new level by expanding our content to other regulatory aspects that concern the generic drug industry.
April 22-23, 2015
The Sheraton Silver Spring Hotel
Silver Spring, MD
This two-day conference offers you the opportunity to interact with FDA subject matter experts as we discuss various topics along the dynamic continuum of the generic drug approval process. This forum will be delivered in a hybrid format (you can attend virtually or in person).
Topics include:
  • Current Regulatory Practice in Type II API DMF Review
  • Update on Question-based Review (QbR)
  • Proper Regulatory Submission During the Lifecycle of Generic Drug Products

This Event is FREE. However, advance registration is required. 

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

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