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U.S. Department of Health and Human Services

Drugs

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CDER Small Business Webinar on CDER Export Compliance and the Certificate of a Pharmaceutical Product (CPP) Application Process - August 8, 2012

The Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Small Business Assistance Program is pleased to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series highlights various aspects of drug regulation.

These focused webinars support the Program’s mission of promoting productive interaction with regulated industry by assisting regulated domestic and international small pharmaceutical business with information relating to the development and regulation of human drug products.

On Wednesday August 8, 2012, we presented our webinar entitled CDER Export Compliance and the Certificate of a Pharmaceutical Product (CPP) Application Process, which discussed the regulatory history of exports, current regulations and the Certificate of a Pharmaceutical Product (CPP).

Our presenters were Huascar Batista and Ms. Betty McRoy:

  • Huascar Batista is the Imports Exports Compliance Branch Chief at FDA Center for Drug Evaluation and Research Office of Compliance.  His branch is located in the new Office of Drug Security, Integrity and Recalls which handles all compliance aspects of drug supply chain, drug shortages, and recall coordination.
  • Ms. McRoy has served as Lead Secretary for CDER’s Division of Anti-Viral Drug Products and as the secretary/technician to the Branch Chief of the Division of Drug Quality Evaluation, Product Surveillance Branch.  Ms. McRoy started with the FDA CDER Export Certificate Program in 2002, and has served as the Program Manager and oversees the daily operations since 2007.

For More Information:

http://www.fda.gov/smallbusinessdrugs

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