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Mandarin Oriental Washington D.C.

Jan 25, 2016 8:30 AM - Jan 27, 2016 3:00 PM

1330 Maryland Avenue, SW, Washington, DC 20024

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

E. Stewart Geary, MD

MD, Global Safety Officer, 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)

Isobel Reid, PHARMD

Isobel Reid, PHARMD

Regional Director, Pharmacovigilance, Intercon, Australia and Canada, Bristol-Myers Squibb, Australia

New PV Regulations: Eurasian Economic Union & Arab Countries

Cristiane Pasin, PHARMD

Cristiane Pasin, PHARMD

Country Safety Lead, Pfizer, Brazil

Pharmacovigilance in Brazil

E. Stewart Geary, MD

E. Stewart Geary, MD

MD, Global Safety Officer, Eisai Co., Ltd., Japan

Pharmacovigilance Compliance Challenges in China, Korea and Japan

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