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Session 6: Impact of EU GVP Module IX on Global Labeling Goverance
Session Chair(s)
A. Leander Fontaine, MD
President, Pharmiceutics, LLC., United States
This session discusses the potential implications of the safety-labeling submission requirements added to the revised EU GVP Module IX on companies’ global labeling actions, policies, and processes.
Learning Objective : At the conclusion of this session, participants should be able to:- Discuss the new requirements for the timing of safety labeling variations in GVP Module IX (Rev. 1)
- Analyze the potential impact on their company’s labeling global process
Speaker(s)
The Revised GVP Module IX and its Potential Impact on Global Labeling Processes - Introduction
Barbara Lachmann, MD
Sole Proprietor, Barbara Lachmann Labeling Consulting, Germany
Understanding the Labeling-Related Requirements of the Revised GVP Module IX
Elisabethann Wright
Partner, Hogan Lovells International LLP, Belgium
The New Labeling Submission Requirements in GVP Module IX – A USA Legal Point of View
Lynn W. Mehler, JD
Partner, HoganLovells, United States
Panelist
Shinobu Uzu, PhD
Senior Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Panelist
Deborah Bebbington
Head Global Labeling, Bayer Plc, United Kingdom
Panelist
Kiernan Trevett, MSc
Quality Policy Lead, Genentech, A Member of the Roche Group, United States
Panelist
Paula Hudson, RPh, RAC
Director, Global Labeling, Eli Lilly and Company, United States