Instructors
Mark Alan DeWyngaert, PhD, MA, MBA
Managing Director, Deloitte, United States
Dr. DeWyngaert trained as a molecular biologist and has been actively involved in both research and business development roles for over 30 years. He has provided operational, clinical, managerial, consulting, and litigation services to various segments of the health care industry. He specializes in assisting pharmaceutical manufacturers, biotechnology, and medical device companies with identifying and mitigating regulatory risks, valuing intellectual property and litigation support.
Monica Kwarcinski, PharmD
Vice President, Medical Affairs, Purdue Pharma L.P., United States
Monica Kwarcinski is currently the Vice President of Medical Affairs at Purdue Pharma. In this role Monica oversees Medical Information, MSLs, Medical Communications and Strategy, Health Economic and Outcomes Research, Epidemiology, and FDA Postmarketing Requirement studies. Prior to joining Purdue Pharma, Monica held various positions of increasing responsibilities within Abbott Laboratories Medical Affairs Department. She received her PharmD from Creighton University in Omaha, Nebraska followed by a Drug Information Residency University of North Carolina, Chapel Hill and Glaxo. Monica has 25+ years of industry experience and frequently speaks on topics related to industry medical communications compliance and department processes.
Gary Messplay, JD
Partner, King & Spalding, LLP, United States
Gary Messplay is a Partner in the Washington, D.C., office of King & Spalding. He represents life sciences clients before the Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and other federal and state agencies. Mr. Messplay's practice includes regulatory and administrative law matters, clinical trials, criminal and civil enforcement matters, healthcare compliance, internal investigations, litigation, liability counseling, and transactional work related to pharmaceutical products. He has written extensively about pharmaceutical compliance issues and is a frequent speaker on regulatory and compliance matters. He is a member of the Food and Drug Law Institute, where he serves on FDLI’s Editorial Advisory Board.
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