Priya Gopal, Associate Director, Strategic Planning and Projects, Novartis to Speak at the Knowledge Group’s Exploring the Drug Supply Chain Security Act (DSCSA) and its Impact to Drug Manufacturers, Wholesalers, and Pharmacies LIVE Webcast. Please refer to the below for more information.
New York City, United States, June 5, 2014 - (PressReleasePoint) - The Knowledge Group/The Knowledge Congress Live Webcast Series, the leading producer of regulatory focused webcasts, has announced today that Priya Gopal, Associate Director, Strategic Planning and Projects, Novartis will speak at the Knowledge Group’s webcast entitled: “Exploring the Drug Supply Chain Security Act (DSCSA) and its Impact to Drug Manufacturers, Wholesalers, and Pharmacies.” This event is scheduled for August 11, 2014 from 12:00pm – 2:00pm (ET).
Priya Gopal is a Associate Director, Strategic Planning and Projects for Novartis . She is a program manager for serialization and product tracking for Novartis , US. She has been with Novartis for more than ten years playing various global roles in strategic planning and in program management. Priya was one of the key players in integrating of newly acquired companies Nektar and Chiron to Novartis. Priya has US lead for global wide supply chain optimization program.
Priya has her MBA in finance and is a board member of PDSA (Pharma drug security alliance)
On November 2013, President Obama signed into law The Drug Quality and Security Act (DQSA), which includes in Title II the Drug Supply Chain Security Act (DSCSA). DSCSA authorizes the Food and Drug Administration (FDA) to develop a track-and-trace system to protect the public from counterfeit, adulterated, and diverted products. The law replaces State level e-Pedigree regulations.
Title I of DQSA establishes Food and Drug Administration (FDA) over-sight of drug compounding under Section 503A of the Food, Drug and Cosmetic Act (FD&C) and creates a new section, 503B, that provides over-sight of a new class of manufacturers – large compounding entities called ‘outsourcing facilities.’ These entities will be subject to FDA registration, regulation, and reporting requirements (list of products compounded, active ingredients, and adverse effects).
This law comes in response to a meningitis outbreak attributed to tainted steroid injections that caused 64 deaths and sickened hundreds in 2012.
Title II of DQSA known as DSCSA paves the way for an electronic tracking system to prevent counterfeited or stolen prescription drugs from entering the U.S. Within four years, drug manufacturers will have to include serial numbers on all drug packages and, within 10 years, to track serialized medicines from manufacturing facilities to pharmacies. Pharmaceutical wholesale licensing standards, transaction verification, and lot -level tracking, requirements come into effect as early as Jan 1, 2015.
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