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Boston Convention and Exhibition Center

2018 年 06 月 24 日 8:30 上午 - 2018 年 06 月 24 日 12:00 下午

415 Summer Street, , Boston, MA 02210 , USA

#25: Precedent: A Driver of Regulatory Strategy


Kimberly  Belsky, MS

Kimberly Belsky, MS

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

Kimberly (Kim) Belsky is a regulatory professional with expertise in Regulatory Policy & Intelligence and AdPromo. With over 30 years of global experience in the medical product industry, including 20+ years in regulatory affairs, Kim's diverse experience including scale up and tech transfer, quality/compliance, advertising & promotion, labeling, and regulatory policy and intelligence. Her background includes Rx drug/biologics, OTCs/Nutritionals/Cosmetics, and medical devices. Kim is the co-chair of the DIA AdPromo WG (part of the RegAffairs Community) and is an active member in RAPS. Kim is passionate about networking, learning, and 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.