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.
• Is an up-to-date practical guide on conceiving, designing and implanting
global therapeutic risk management plans for medicines
• A number of useful frameworks are presented which add impact to RMPs (Risk Management Plan), together with regional specific information (EU, US and Japan).
- Introduction and historical background of risk management plans
- EU-RMP (Risk Management Plan) - regulations and requirements
- USA REMS (Risk Evaluation and Mitigation Strategies) - regulations and requirements
- Safety specification
- Pharmacovigilance planning
- Assessing the need for risk minimization - strategies and approaches
- Risk minimization tools
- Implementation of RMPs and REMS
- Evaluation of RMPs and REMS
- Developmental risk management plans
- Effectively negotiating with the health authorities
- Public communication of benefit risk
Pharmaceutical industry staff (clinical development, safety, risk, regulatory, marketing, outcomes research), regulators, pharmacologists, pharmacists, healthcare payors, policy makers, undergraduate and postgraduate pharmacy, pharmacology and medical students.
Banerjee, Anjan K. Dr
The principal author is Dr Anjan 'Swapu' Banerjee, who is is a Pope Woodhead & Associates (Cambridgeshire, UK) Board Member, Director of Development Consulting and Head of Regulatory and Risk Management Practice and has wide experience of over 30 global risk management programmes, is a member of the eNcePP network of EMA and has been involved in multiple EU and US regulatory filings, regulatory projects and the design of clinical development programmes. He is also a Teaching Associate in drug safety and risk management at the Institute of Biotechnology, Cambridge University, and has published widely in the field, and has supervised over 10 MPhil students from his programme. Swapu joined Pope Woodhead from Roche where he was a Global Drug Safety Scientist (Physician). Swapu has over 10 years' experience in global pharmaceuticals, biotech and devices (clinical development, medical marketing), and more than 25 years' experience in healthcare, as well as being a practicing general and colorectal surgeon.
Whilst a Management Consultant with McKinsey & Co, he completed a number of projects in pharmaceutical and medical devices, market strategy, in-licensing, M&A, clinical development and emerging markets. He has had formal training in Pharmaceutical Medicine and has completed an MSc in Pharmacoepidemiology at the University of Surrey.
Swapu is medically qualified with a higher research doctorate equivalent, has finance training (Securities Institute) and is MBA, MRCP, FICS, MFPM and has been elected a Fellow of the Society of Biology (FSB).
Some chapters are contributed - by distinguished industry, medical, academic and regulatory experts in therapeutic risk management plans for medicines.