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CDER Small Business and Industry Assistance (CDER SBIA) Webinar on The Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act): Overview & Implementation - March 12, 2014

 

The Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA) 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 CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting regulated domestic and international small pharmaceutical business and industry with information relating to the development and regulation of human drug products.
 
On March 12, 2014, CDER Small Business and Industry Assistance (CDER SBIA) presented a webinar entitled The Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act): Overview & Implementation.
 
The purpose of this webinar was to highlight key aspects of the Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act), FDA’s implementation plan for the law and the docket currently open for comment regarding Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format.
 
Speaker:
Ilisa B.G. Bernstein, Pharm.D., J.D.
Deputy Director, Office of Compliance
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)
 
Dr. Ilisa Bernstein is the Deputy Director of Office of Compliance in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA).  She leads this Office in promoting and protecting public health through outreach, strategies and actions that minimize consumer exposure to unsafe, ineffective, and poor quality drugs.
 
Ilisa started her career at FDA in 1988 as a Pharmacokinetic Reviewer in CDER, where she was responsible for reviewing and evaluating the pharmacokinetic aspects of investigational drugs used for AIDS and HIV infection. From 2002 to 2003, Ilisa was a Senior Associate Director at Pfizer, Inc. in the Regulatory Liaison Office in Rockville, Maryland. She served as a liaison between Pfizer and FDA, and provided guidance and advice on emerging policies, regulations, and legislation and their impact on Pfizer’s global operations. Ilisa completed a post-doctoral residency at the National Institutes of Health, focusing on clinical and research pharmacokinetics.
 
Ilisa received her Doctor of Pharmacy degree from The University of Michigan College of Pharmacy and her Juris Doctor degree from The American University Washington College of Law.
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Presentation Information

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For More Information:
http://www.fda.gov/smallbusinessdrugs
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