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Changing Environments Within Pharmacovigilance
Session Chair(s)
Stella Blackburn, MD, MA, MSC, FFPM, FISPE, FRCP
Strategy
Consultant, United Kingdom
Updates in pharmacovigilance and safety in various markets with changing regulatory environments. Speakers will include: FDA, EMA, as well as other key regions such as Japan, China, and emerging markets like Africa.
Learning Objective : Discuss changes in regional and global regulations and how they impact one's pharmacovigilance organization.
Speaker(s)
Navigating Through the World of Combination Product Safety
Khaudeja Bano, DrMed, MD, MS
Genentech, United States
Vice President, Combination Product Quality
Regulatory Scientific Significance of Japan’s Postmarketing Adverse Event Relief System
Toshiyoshi Tominaga, PHD
SunFlare Co., Ltd, Japan
Life Science Department, Advisor
Overview of Changes to the FDA Pharmacovigilance Regulatory Landscape
LaShanda Long, MS
FDA, United States
Supervisor, Office of Scientific Investigations, OC, CDER