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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

avatar for Kimberly Belsky

Kimberly Belsky

Executive Director, Regulatory Policy and Intelligence, Regulatory Affairs, Mallinckrodt Pharmaceuticals
Kimberly (Kim) Belsky is the Executive Director of Regulatory Policy & Intelligence at Mallinckrodt Pharmaceuticals (MNK) assessing key changes in the global regulatory environment and providing strategic insights to the company regarding impact on the portfolio and activities. With... Read More →
avatar for Robert Kester

Robert Kester

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... Read More →

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