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Nov 04, 2015 11:30 AM - Nov 04, 2015 1:00 PM

(Eastern Standard Time)

Online

CSRC/DIA: Social Listening and Safety Surveillance—Enabling Opportunities for Cardiac Safety

Presenters

John K. Finkle, MD, FACC, FACP

John K. Finkle, MD, FACC, FACP

Vice President, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, United States

Dr. Finkle is boarded in Internal Medicine, Cardiology and Clinical Cardiac Electrophysiology. He works in the Clinical Safety Department at GSK and is Chair of the Global QT and Cardiology Safety Panels. Dr. Finkle also sits on Executive Steering Committee of the Cardiac Safety Research Consortia

Harry A Seifert, MD

Harry A Seifert, MD

Medical Director, Clinical Safety Sciences, Glaxosmithkline, United States

Gregory  Powell, PharmD, MBA

Gregory Powell, PharmD, MBA

Senior Director, Safety and Clinical Innovation, GlaxoSmithKline, United States

Greg Powell is the Senior Director of Safety and Clinical Innovation at GlaxoSmithKline. He completed his PharmD at the University of Florida, his MBA at East Carolina University, and his BS in Pharmacy at the University of North Carolina. He has over twenty years of experience practicing pharmacovigilance across the entire product life cycle. Additionally, he has focused on advancing the science of pharmacovigilance working with various data/methods that range from traditional data sources such as spontaneous, clinical trial, and observational to emerging data sources such as social media, crowdsourcing, and artificial intelligence. He has extensively published his work in various journals and presented at various conferences.

I. Glenn  Cohen, JD

I. Glenn Cohen, JD

Faculty Dir, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, Harvard University, United States

Luke C. Gelinas, PhD, MA

Luke C. Gelinas, PhD, MA

Senior Advisor, MRCT Center; Chairperson, Advarra IRB, United States

Mary Ross  Southworth, PharmD

Mary Ross Southworth, PharmD

Deputy Director for Safety, Division of Cardiovascular and Renal Products , FDA, United States

She is the Deputy Dir. of Safety (Div. of Cardiovascular/Renal Products). Responsibilities include evaluation of NDAs under review for relevant post-marketing activities such as Risk Evaluation and Mitigation Plans, enhanced pharmacovigilance, and required post-marketing studies.

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