New medicines have always had risks as well as benefits but until recently, the majority of major drug safety catastrophes arose unpredictably. Many potentially useful drugs have also had approvals delayed or denied due to inadequate benefit risk planning and mitigation. Risk management plans are mandatory for new drug filings in Europe since 2004; in the US, a Risk Evaluation and Mitigation Strategies (REMS) is needed for selected drugs. The legislation has evolved rapidly over the last decade and the authors provide an authoritative, yet practical, guide on planning, writing, implementing and evaluating risk management plans for medicines globally. Chapters, some of which feature contributions from distinguished industry and regulatory experts, explain the historical development, lessons from other industries, regulatory and health authority perspective and public communication of benefit risk.
Genre: Freedom + Security / Law Enforcement, Medical, Business + Money Management
Subgenre: Pharmacology, Medical Law + Legislation, Management