Therapeutic Risk Management of Medicines

by Mayall; Banerjee

• ISBN13: 9781907568480
• ISBN10: 1907568484
• Edition: 1st
• Format: Paperback
• Copyright: 2018-10-30
• Publisher: Elsevier Science

Summary

New medicines have always had risks as well as benefits but, until recently, the majority of major drug safety catastrophes arose unpredictably, often with devastating public health consequences. Many potentially useful drugs have also had approvals delayed or refused due to inadequate benefit risk planning and mitigation. Risk management plans are compulsory for new drug filings in Europe since 2004, and in the US for selected drugs a REMS (Risk Evaluation and Mitigation Strategies) is needed. The legislation has evolved rapidly over the last decade and this book is an authoritative, and yet practical guide on planning, writing, implementing, evaluating risk management plans for medicines globally. Chapters are also included on the historical development, lessons from other industries, the regulatory and health authority perspective and public communication of benefit risk. This topic is of critical importance not only to the pharmaceutical and biotechnology industry, but also prescribers, pharmacists, regulators and healthcare policymakers.