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Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr.

Apr 24, 2017 7:30 AM - Apr 26, 2017 12:00 PM

1750 Rockville Pike, , Rockville, MD 20852 , USA

CMC Workshop

Session 4A: Global Landscape of Falsified Medicines and Global Landscape of Serialization

Session Chair(s)

Terrance  Ocheltree, PhD, RPh

Terrance Ocheltree, PhD, RPh

VP, Head of Regulatory Affairs and Quality Assurance

Corium, Inc., United States

To combat the increasing risk of falsified medicines in the global market many countries have or plan to initiate serialization and traceability requirements. The lack of coordination of these efforts has the potential to create conflicting requirements and complex operational challenges for all stakeholders in the pharmaceutical supply chain. This session will highlight the current challenges facing the pharmaceutical industry to track and trace global medicinal products, discuss harmonized approaches pertaining to serialization, and provide a regulator’s perspective to addressing falsified medicines. During the panel discussion, you will have the opportunity to ask questions and share ideas on approaches to secure pharmaceutical products supply chains to ensure that patients receive safe and effective medicinal products.

Speaker(s)

Eleni  Anagnostiadis, RPh

Supply Chain Integrity: FDA Perspective on Falsified Medicines and Serialization

Eleni Anagnostiadis, RPh

FDA, United States

Director, PASES, OCD, CDER

Eric M. Marshall, JD

Global Development in Serialization and the Need for Harmonization

Eric M. Marshall, JD

Leavitt Partners, United States

Senior Director

Lloyd  Mager

DSCSA - Drug Supply Chain Security Act

Lloyd Mager

AbbVie, United States

Global Traceability Lead

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