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Short Course #1: Medical Communications: Compliance in 2022


Instructors

  • Monica  Kwarcinski, PharmD

    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

    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.

  • Raegan  McClain, JD, LLM

    Raegan McClain, JD, LLM

    • Chief Compliance Officer
    • Oyster Point Pharma, Inc., United States

    Raegan has over 20 years of legal and compliance experience working in large and specialty global pharmaceutical and medical device organizations. She began her career as an attorney in a large law firm in Chicago and has worked in small, midsized and large life sciences companies in legal and compliance roles where she was responsible for partnering with cross-functional teams to strategically build and evolve corporate healthcare compliance programs to support commercialization. She held her first in-house role at Sanofi-aventis and most recently served as Chief Compliance Officer at OptiNose US, Inc. Raegan has a B.S. from The Pennsylvania State University, a J.D. from The University of Pittsburgh and an LL.M. in Health Law from Loyola