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Safety and Social Media: Is this the Question or the Answer

Speakers

Elizabeth E. Garrard, PHARMD

Elizabeth E. Garrard, PHARMD

Executive Vice President, Global Safety Operations , Clinipace Worldwide, United States

Beth has more than 20 years of experience in pharmaceutical product safety based on monitoring adverse event data from use in medical practice for both clinical investigations and postmarketing. Her experience includes extensive industry-based global pharmacovigilance with both CROs and sponsor-based companies where her focus has been operational efficiencies, risk management, and data visualizations for signal detection. She completed her BS in Pharmacy and Doctorate in Pharmacy at UNC’s School of Pharmacy in Chapel Hill, NC.

Linda J. Scarazzini, MD, RPH

Linda J. Scarazzini, MD, RPH

Vice President, Pharmacovigilance and Patient Safety, AbbVie, United States

She is currently Vice President, Head of Pharmacovigilance and Patient Safety at AbbVie. Prior to joining AbbVie, Dr. Scarazzini served as Director of the Division of Pharmacovigilance in the Office of Pharmacovigilance and Epidemiology, CDER, FDA. She began her career in pharmacovigilance at Sanofi-Aventis, ultimately serving as Associate Vice President of Pharmacovigilance and Risk Management. In 2016, she was selected by her industry peers to serve as the BioPharma Representative on FDA Drug Safety and Risk Management Advisory Committee. Dr Scarazzini’s publications include the recently-released textbook “Pharmacovigilance: A Practical Approach,” as co-author and co-editor along with members of her AbbVie PV team

Michael A. Ibara, PHARMD

Michael A. Ibara, PHARMD

Chief Data Officer, Elligo Health Research, United States

20+ years’ experience in clinical R&D. Previously Head of Digital Healthcare for CDISC. Prior to that 15 yrs at Pfizer, leading implementations of global systems. Pioneered ASTER - the first time AEs were retrieved directly from an EHR and sent to FDA. Current work FDA project to harmonize common data models, development of a RWD safety approach for iSPY2+ OneSource project, and application of practical ontologies to fundamental issues in eSource. Pharm.D. U. of Michigan, Fellowship Drug R&D

Brian  Overstreet

Brian Overstreet

President and Chief Executive Officer, Advera Health Analytics, United States

Nabarun  Dasgupta, PHD, MPH

Nabarun Dasgupta, PHD, MPH

Chief Science Officer, Epidemico, Inc. , United States

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