Boston Convention and Exhibition Center

2018年6月24日 (日) 午前 8:30 - 2018年6月24日 (日) 午後 12:00

415 Summer Street, , Boston, MA 02210 , USA

#25: Precedent: A Driver of Regulatory Strategy

Instructors

Kimberly  Belsky, MS

Kimberly Belsky, MS

Reg Policy & Intell and AdPromo, Regulatory Affairs, Independent, United States

Kimberly (Kim) Belsky is a seasoned regulatory professional specializing in Regulatory Policy, Intelligence, and Advertising & Promotion (AdPromo). With over 30 years of global experience in the medical product industry, including more than 20 years in regulatory affairs. Her diverse background spans prescription drugs, biologics, over-the-counter products, nutritionals, cosmetics, and medical devices. She also happily co-chairs the DIA AdPromo Working Group within the Regulatory Affairs Community and is actively involved in the Regulatory Affairs Professional Society (RAPS). Kim is passionate about networking, learning, sharing insights and fostering collaboration.

Robert  Kester, MA, MS

Robert Kester, MA, MS

Senior Director, Global Regulatory Affairs, Merck & Co., Inc., United States

Robert Kester is a Senior Director, Global Regulatory Liaison Oncology at Merck & Co. Inc. He has been at Merck for more than eight years and began as a Regulatory Liaison focused on developing Rest of World regulatory strategies before transitioning to his current role in 2016 supporting the global development strategy of oncology products. In his current role, he is a Global Regulatory Team Lead for the lung cancer program and led one of the first RTOR submissions to the US FDA. During his time at Merck, he has also served as a Chief of Staff and has provided regulatory intelligence support to the group. Prior to joining Merck, Robert obtained his MA from Harvard University and worked at Roche for 15 years as a Discovery Chemist.

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