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Sunday, June 24 • 8:30am - 12:00pm
#25: Precedent: A Driver of Regulatory Strategy

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Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

This course will review regulatory precedent (and the pathway to locate, assess, and integrate) as a global regulatory strategic driver. Precedent case studies will be used to identify challenges when limited information is publicly available and how to interpret precedent. Attendees will engage through analysis of a hypothetical development program and explore the types of questions that would be critical to successfully integrate precedent for regulatory success. An additional registration fee is required for all preconference short courses.

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Who should attend?

This short course is designed for professionals with basic knowledge in Regulatory (strategy, CMC, regulatory intelligence), Clinical, Project management, competitive intelligence, and business development

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Evaluate global regulatory precedent, assess its value and integrate to drive regulatory strategy decision making and determine what to do when no precedent exists
  • Identify precedent for risk assessment and mitigation planning as well as opportunities for success in approval and lifecycle management



Speakers
avatar for Kimberly Belsky

Kimberly Belsky

Senior Director, Regulatory Affairs, Regulatory Policy and Intelligence, Mallinckrodt Pharmaceuticals
Kimberly (Kim) Belsky is a Sr. Director of Regulatory Intelligence at Mallinckrodt Pharmaceuticals. Prior to that, Kim was an Executive Director at OneSource Regulatory (OSR) and an Executive Director of AdPromo, Labeling, and Policy in Regulatory Affairs at Valeant Pharmaceuticals... Read More →
avatar for Robert Kester

Robert Kester

Director, Global Regulatory Affairs, Merck & Co., Inc.
Robert Kester is a Director, Global Regulatory Liaison, in the Oncology & IVD group at Merck & Co. Inc. He has been at Merck for more than five years and began as a Regulatory Liaison focused on developing Rest of World regulatory strategies for cardiovascular and oncology products... Read More →


Sunday June 24, 2018 8:30am - 12:00pm
Room 160C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA