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Mandarin Oriental Washington D.C.

2016年1月25日 (月) 午前 8:30 - 2016年1月27日 (水) 午後 3:00

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.

Session 2 – FDA Updates

Session Chair(s)

Gerald  Dal Pan, MD, MHS

Gerald Dal Pan, MD, MHS

Director, Office of Surveillance and Epidemiology, CDER

FDA, United States

In this session, FDA representatives will provide updates from the Office of Surveillance and Epidemiology (OSE) within CDER. Topics will include postmarketing safety monitoring within OSE, an overview of pharmacovigilance, pharmacoepidemiology, pharmaceutical risk management, and medication error prevention.

Speaker(s)

Linda  Belmont, MD

Linda Belmont, MD

DIA, United States

Project Coordinator, Learning & Digital Solutions

Gerald  Dal Pan, MD, MHS

Postmarketing Drug Safety at FDA

Gerald Dal Pan, MD, MHS

FDA, United States

Director, Office of Surveillance and Epidemiology, CDER

Claudia  Manzo, PharmD

REMS Update

Claudia Manzo, PharmD

FDA, United States

Director, Office of Medication Error Prevention and Risk Management, OSE, CDER

Chrissy  Cochran, PhD

REMS Compliance

Chrissy Cochran, PhD

FDA, United States

Director, Office of Bioresearch Monitoring Operations, ORA

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