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Hyatt Regency Bethesda

Nov 13, 2013 7:15 AM - Nov 14, 2013 4:30 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

DIA Biosimilars 2013

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Postmarketing and Risk Management

Session Chair(s)

Sumant Ramachandra, MD, PhD, MBA

Chief Scientific Officer & Senior VP of R&D and Medical Regulatory Affairs

Hospira, Inc., United States

In this session, industry experts in pharmacovigilance will provide perspectives on post-approval safety evaluations and risk management plans/REMS for biologics and biosimilars. Using case studies, global experience with such programs will be reviewed with a focus to understanding challenges and opportunities.

Speaker(s)

Post-marketing Requirements and Pharmacovigilance

Freddy J Faccin

AbbVie, Puerto Rico

Assoc. Medical Director, Lat. America Biotherapeutics, Immunology Medical Affair

Trending, Signal Detection and Risk

Juergen Schmider, MD, PhD

Pfizer Inc., United States

Vice President, Pharmacovigilance & Safety Evaluation and Reporting

Martina Weise, DrMed, MD

Panel Discussion - Additional Speaker

Martina Weise, DrMed, MD

Bfarm, Germany

Head, Licensing Division 2, BfArM; German CHMP Alternate

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