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Session 4A: Global Landscape of Falsified Medicines and Global Landscape of Serialization
Session Chair(s)
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
Director, PASES, OCD, CDER, FDA, United States
Supply Chain Integrity: FDA Perspective on Falsified Medicines and Serialization
Eric M. Marshall, JD
Senior Director, Leavitt Partners, United States
Global Development in Serialization and the Need for Harmonization
Lloyd Mager
Global Traceability Lead, AbbVie, United States
DSCSA - Drug Supply Chain Security Act
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