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Session 2 - EU Pharmacovigilance Guidelines – Impact on Global Labeling: Strategies for Industry
Session Chair(s)
A. Leander Fontaine, MD
President
Pharmiceutics, LLC., United States
Speaker(s)
Panelist
Joseph McMillian
Heartland Compliance Services LLC, United States
Principal Partner
Panelist
Ralf Zerban, DrMed
Vigiserv GmbH, Germany
Managing Director
Panelist
Barbara Lachmann, MD
Barbara Lachmann Labeling Consulting, Germany
Sole Proprietor
Panelist
Julie P. Retzinger, MBA, RN
Astellas Pharma Inc., United States
Senior Director - Global Labeling and CCDS
Panelist
Gerrit Nijveldt, MS, MSC
Opus Regulatory, United States
Global Labeling Consultant
Panelist
Rie Matsui, RPH
Pfizer R&D Japan G.K., Japan
Senior Director, Regional Labeling Head for APAC
Panelist
Megann Looker
Jazz Pharmaceuticals, United Kingdom
Executive Director, Head of Global Labeling
Panelist
Su-Yueh Lin
SYL Regulatory Consulting, Taiwan
Sr. Labeling Consultant, Regulatory Affairs
Panelist
Takashi Misu, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Coordinator, Office of International Strategy and Planning
Panelist
Bruce Boulton, MSC
Health Canada, Canada
Product Information Officer, Bureau Gastroenterology, Infection & Viral Diseases
Panelist
Anna Toth, PHARMD, MSC
Medical Products Agency, Sweden
Pharmacovigilance Inspector, Drug Inspectorate Industry & Hospital
Mark Collins, PHD, MBA
Opus Regulatory, United States
Principal Consultant