David Colombo, Director, KPMG LLP to Speak at the Knowledge Group’s Drug Supply Chain Security Act Event

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David Colombo, Director, Advisory Services, KPMG LLP 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. See 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 David Colombo, Director, Advisory Services, KPMG LLP 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).

About David Colombo

David is a director in KPMG’s Advisory Services practice with more than 20 years of operational, engineering and IT experience in supply chain execution, primarily in the pharmaceutical industry, including both clinical and commercial chains. He has a strong background in order-to-cash processes, logistics/distribution operations, and supporting technical and IT platforms. David has substantial experience in supply chain execution processes in all countries/regions of the world. He supports clients seeking technical and functional guidance with pharmaceutical product serialization and traceability requirements, as well as UDI (Unique Device Identification) requirements for medical device manufacturers.

Event Synopsis:

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. To learn more, please visit: http://theknowledgegroup.org/event_name/the-drug-quality-and-security-act-hr-3204-implications-for-drug-manufacturerspharmacies-and-healthcare-live-webcast/

About The Knowledge Group, LLC/The Knowledge Congress Live Webcast Series

The Knowledge Group, LLC was established with the mission to produce unbiased, objective, and educational live webinars that examine industry trends and regulatory changes from a variety of different perspectives. The goal is to deliver a unique multilevel analysis of an important issue affecting business in a highly focused format. To contact or register to an event, please visit: http://theknowledgegroup.org/


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