Menu Back toSession-10-Emerging-Regions-Issues

Pharmacovigilance and Risk Management Strategies Conference

NEW! The 2019 meeting will be a full three days, allowing maximum learning opportunities!


Session 10: Emerging Regions Issues

Session Chair(s)

E. Stewart  Geary, MD

E. Stewart Geary, MD

  • Senior Vice President and CMO
  • Eisai Co., Ltd., Japan
As China has joined the ICH community it has leaped ahead in published requirements for electronic reporting (E2B(R3)) during clinical trials and requests for Risk Management Plans sometimes without detailed guidance or the infrastructure for clinical trial sponsors and marketing authorization holders to be confident in their path to compliance. The current, rapidly evolving situation in China for these requirements will be presented along with suggestions on how industry can meet the expectations of the Chinese regulatory authorities. Since the adoption of the Pharmacovigilance System Master File in the EU, a number of non-EU countries have indicated interest in adopting formal or informal requirements for a local PSMF. A presentation will be given on how a coordinated approach to generating and maintaining a PSMF for regulators outside the EU
Learning Objective : Upon completion of this session, the participant should be able to:
  • Prepare for compliance with new Pharmacovigilance regulations in China
  • Implement strategies for global management of PSMF’s (no's)including for countries outside the EU
  • Describe different practical approaches to PSMF management

Speaker(s)

Dionne  Usher

The Adventures of the Pharmacovigilance System Master File Outside the European Union

Dionne Usher

  • Associate Director, Office of the EU QPPV
  • Merck Sharp & Dohme Limited, United Kingdom
Han  Ma

Updates of China Regulatory and Pharmacovigilance Environment

Han Ma

  • Asia Pacific Site Head
  • Roche, China
Naomi  Morris, MS

PSMF – A Global Perspective

Naomi Morris, MS

  • Head of QPPV Compliance Office
  • Pfizer Srl., Italy