DESCRIPTION

Puzzled by REMS? We have the answer for you!
Pharmaceutical Risk Management:
Practical Applications

With a Foreword by Janet Woodcock, MD, Director of FDA’s Center for Drug Evaluation and Research.

In today’s new world of Risk Evaluation and Mitigation Strategy (REMS), drug companies need experienced guidance to help them succeed in pre- and post-marketing drug development and approval. The authors and contributing experts provide you with the day-to-day practical guidance needed to understand, plan and implement successful risk management programs. Each chapter is a stand-alone dissertation by a contributing expert on a specific segment of risk management. Included are chapters on the environmental and historical context for risk management; examples and case studies; and strategic considerations about crisis management and legal implications of risk management. This publication offers insight into the FDA’s evolving thinking on the REMS process and application.

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Book