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Tuesday, June 20 • 10:30am - 11:45am
#230: Global Harmonization: Mutual Recognition

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Despite efforts to harmonize regulatory requirements, the proliferation of divergent expectations continues to unnecessarily complicate management of product supply chains. While divergent regulatory requirements are largely the result of local economic drivers, the impact on regulatory approvals, inspections, change management and inventory limits continuous improvement and optimization of manufacturing and is ultimately challenging for industry and regulatory authorities globally.

Learning Objectives

Discuss the challenges of global harmonization on the management of the product supply chain

Chair

Roger Nosal

Speaker

EU-FDA Mutual Recognition Agreement for GMP Inspections
Niraj Mehta, PhD

Industry Perspective
Chi-Wan Chen, PhD

Postapproval Change Management Protocols: Future Opportunities
Terrance Ocheltree


Speakers
CC

Chi-Wan Chen

Executive Director, Global CMC, Pfizer Inc.
Chi-wan Chen is Executive Director in Global CMC, Pfizer, responsible for regulatory CMC policies and strategies with a focus on Asia Pacific. She has made numerous presentations on regulatory and CMC in or on AP. Prior to joining Pfizer in 2008, She had served in US FDA for over... Read More →
avatar for Niraj Mehta

Niraj Mehta

Associate Director for Global Regulatory Policy, GO, OC, FDA
Niraj Mehta, Ph.D., is the Associate Director for Global Regulatory Policy in the Office of Global Regulatory Operations and Policy at the U.S. Food and Drug Administration. Dr. Mehta was a key member of team that negotiated the amended Pharmaceutical Annex to the 1998 US-EU Mutu... Read More →
avatar for Roger Nosal

Roger Nosal

Vice President and Head, Global CMC, Pfizer Inc.
Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several PhRMA, ICH, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical c... Read More →
avatar for Terrance Ocheltree

Terrance Ocheltree

Senior Director Regulatory Policy and Intelligence, AbbVie, Inc.
Terry is a Sr. Director in Regulatory Policy and Intelligence at AbbVie. He has a BA in Business and BS in Pharmacy, a PhD in Pharmaceutics. Having worked in retail and hospital pharmacy prior to joining the industry, Terry has over 30 years of pharmacy and pharmaceutical experie... Read More →

Tuesday June 20, 2017 10:30am - 11:45am
S402ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  11: Quality, Session
  • format json
  • Credit Type CME, IACET, RN
  • Tags Session