Pharmacovigilance and Risk Management Strategies 2016

Discuss opportunities, challenges, and practical aspects of managing risk in the context of benefits, for medical product safety and pharmacovigilance.

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Session 3 – Maturing Markets Regulatory Updates

Session Chair(s)

E. Stewart Geary, MD

Senior Vice President

Eisai Co., Ltd., Japan

This session will provide an introduction to regulations and practices for pharmacovigilance and risk management in the Middle East, Latin America and Russia including requirements for expedited and periodic reporting during clinical development and post-marketing and any requirements for Risk Management Plans. It will also give a focused description of current challenges for pharmacovigilance and risk management in Northeast Asia (China, Japan, Korea) and what companies need to do to assure regulatory compliance.

Speaker(s)

New PV Regulations: Eurasian Economic Union & Arab Countries

Isobel Reid, PharmD

Bristol-Myers Squibb, Australia

Regional Director, Pharmacovigilance, Intercon, Australia and Canada

Pharmacovigilance in Brazil

Cristiane Pasin, PharmD

Pfizer, Brazil

Country Safety Lead

Pharmacovigilance Compliance Challenges in China, Korea and Japan

E. Stewart Geary, MD

Eisai Co., Ltd., Japan

Senior Vice President

Pharmacovigilance and Risk Management Strategies 2016

Session 3 – Maturing Markets Regulatory Updates

Session Chair(s)

E. Stewart Geary, MD

Speaker(s)

New PV Regulations: Eurasian Economic Union & Arab Countries

Pharmacovigilance in Brazil

Pharmacovigilance Compliance Challenges in China, Korea and Japan

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