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Omni Shoreham Hotel

22 ene 2018 7:00 a.m. - 24 ene 2018 5:00 p.m.

2500 Calvert Street NW, , Washington, DC 20008 , USA

Pharmacovigilance and Risk Management Strategies Conference

Session 8: Advanced Therapeutics Pharmacovigilance and Risk Management

Session Chair(s)

Barbara  Morollo, RN

Barbara Morollo, RN

Head, Pharmacovigilance

Corbus Pharmaceuticals, United States

Advanced therapy medicinal products (ATMPs), which include gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products and tissue-engineered products, are at the cutting edge of innovation and offer patients hope for various diseases for which there are limited or no therapeutic options. The development of ATMPs has sparked considerable interest and debate as there are many unknowns and uncertainties concerning the effects or responses these therapies may evoke, especially in the case of genetic manipulation. This session will examine the challenges associated with monitoring safety and the benefit-risk of these therapies, both short-term and long-term, and explore the complexities associated with determining the safety profile and benefit-risk across common delivery platforms such as gene therapy vectors and lipid nanoparticle delivery systems.

Speaker(s)

Barbara  Morollo, RN

Pharmacovigilance and Risk Management Challenges in Advanced Therapeutics

Barbara Morollo, RN

Corbus Pharmaceuticals, United States

Head, Pharmacovigilance

Jaspal (JP)  Ahluwalia

Speaker

Jaspal (JP) Ahluwalia

FDA, United States

Medical Officer, OBE, CBER

Adrian  Dana, MD

Common Technical Platforms: Benefit-Risk Determination and Risk Management

Adrian Dana, MD

Aimmune Therapeutics, United States

Vice President, Global Patient Safety and Risk Management

Michael  Richardson, MD, FFPM, FRCP

Speaker

Michael Richardson, MD, FFPM, FRCP

Bristol-Myers Squibb, United Kingdom

Senior Vice President, WorldWide Patient Safety

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