Therapeutic Risk Management of Medicines. Este artículo no está disponible.Therapeutic Risk Management of Medicines

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 Therapeutic risk management of medicines is an authoritative, and yet practical guide on planning, writing, implementing and 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. About the Authors Dr Stephen J. Mayall is a senior consultant at Pope Woodhead & Associates. He has over 13 years of consulting and project management experience within the global pharmaceutical industry, and has been involved in therapeutic risk management since 2003. Steve has worked on the development and/or implementation of over 25 risk management plans, including EU-RMPs, REMS, RiskMAPs and developmental-stage RMPs. These have covered a diverse range of therapeutic areas, product types, life cycle stages and client companies. Steve has a Bachelor's degree in natural sciences (biochemistry) from the University of Cambridge, and a PhD in cell biology awarded by University College London for work performed in the laboratory of a Nobel Prize winner. Dr Anjan "Swapu" Banerjee is Pope Woodhead & Associates (Cambridgeshire, UK) Deputy Managing Director and Head of Regulatory and Risk Management Practice. He has wide experience of over 40 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 Faculty member in Regulatory, Drug safety and Risk management at the Institute of Biotechnology, Cambridge University, has published widely in the field, and has supervised over 10 Mphil students from this programme. Swapu joined Pope Woodhead from Roche where he was a Global Drug Safety Scientist (Physician). Swapu has over 15 years' experience in global pharmaceuticals, biotech and devices (clinical development, medical marketing), and more than 30 years' experience in healthcare, as well as being a practising Hon. Consultant General and Colorectal surgeon in the NHS. Swapu is medically qualified with a higher research doctorate equivalent, has finance training (Securities Institute) and is MBA, FRCP(Edin), FRCS(Gen), FRCS(Glas), FAcadMEd, FICS, MFPM and is an FSB. Contents Introduction and historical background of risk management plans; EU-RMP (Risk Management Plan); USA REMS (Risk Evaluation and Mitigation Strategies); Safety specification; Pharmacovigilance planning; Assessing the need for risk minimization; 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.

Dr Stephen Mayall is a Principal Consultant at Pope Woodhead & Associates. He has over 15 years of consulting and project management experience in the global pharmaceutical industry, and has focused on therapeutic risk management since 2003. Steve has worked on the development and/or implementation of over 40 risk management plans, including EU-RMPs, REMS and development-stage RMPs. These have encompassed a diverse range of therapeutic areas, product types, life-cycle stages and client companies. He has also conducted a variety of other consulting projects for global pharmaceutical and biotechnology companies, covering communications, drug safety, clinical development, strategic marketing and in-licensing topics. This broader experience has provided valuable insights for placing risk management in a wider context within different organisations and healthcare systems. Steve has a Bachelor’s degree in natural sciences (biochemistry) from the University of Cambridge, and a PhD in cell biology from University College London.

Dr Anjan “Swapu” Banerjee is Deputy Managing Director (Deputy CEO) of Pope Woodhead & Associates and Head of Development Consulting. He has wide experience of numerous global risk management programmes, is a member of the ENCePP network and has been involved in multiple EU and US regulatory filings, regulatory projects and the design of clinical development programmes. He is also a Faculty member in Regulatory, Drug Safety and Risk Management at the Institute of Biotechnology, Cambridge University. Anjan has over 15 years of experience in global pharmaceuticals, biotech, advanced therapies and devices in clinical development, regulatory, medical affairs and drug safety roles in addition to experience as a Management Consultant at McKinsey & Company. He has spent more than 30 years in healthcare, remaining clinically active as a part-time Honorary Consultant Surgeon at Bedford Hospital NHS Trust. He has completed UK higher medical training in pharmaceutical medicine (as well as general surgery) and has an MSc in pharmacoepidemiology. Anjan is MBBS, DM, MBA, FRCP(Edin), FRCS(Gen), FRCS(Glas), FAcadMEd, FICS, MFPM, FSB.