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

On Wednesday August 8, 2012, at 11 AM EST, the CDER Small Business Assistance Program will present our webinar entitled CDER Export Compliance and the Certificate of a Pharmaceutical Product (CPP) Application Process, which will discuss the regulatory history of exports, current regulations and the Certificate of a Pharmaceutical Product (CPP).

Our presenters will be 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.
Registration website: https://collaboration.fda.gov/export/event/registration.html
(Registration password needs to be 8 characters and alphanumeric)
Web Address for viewing: https://collaboration.fda.gov/exports/
(Presentation will last approximately 1 hr)

Call in numbers (listen only):
Domestic: 888-946-6301
International: 1-312-470-0190
Password (verbal): FDA
For More Information: http://www.fda.gov/smallbusinessdrugs

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