Therapeutic Risk Management of Medicines
Woodhead Publishing Ltd (Verlag)
978-0-08-101417-2 (ISBN)
- Titel wird leider nicht erscheinen
- Artikel merken
A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US.
This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts.
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.
1. Introduction
2. Basic principles of therapeutic risk management
3. The evolution of therapeutic risk management
4. Risk management in the European Union
5. Risk management in the United States
6. Overview of risk management around the world
7. Developing a safety specification and selecting risks
8. Pharmacovigilance planning
9. Assessing the need for risk minimisation
10. Developing risk minimisation plans/risk mitigation strategies
11. Evaluating the effectiveness of risk minimisation
12. Implementing risk management activities
13. Effective interactions with health authorities
14. Development risk management plans
15. Benefit-risk assessment and public communication
16. The commercial importance of risk management and risk-sharing schemes
17. Learnings from other types of risk management
18. The outlook for therapeutic risk management
| Erscheinungsdatum | 14.07.2016 |
|---|---|
| Reihe/Serie | Woodhead Publishing Series in Biomedicine |
| Verlagsort | Cambridge |
| Sprache | englisch |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie |
| Medizin / Pharmazie ► Pflege | |
| Medizin / Pharmazie ► Pharmazie | |
| Studium ► Querschnittsbereiche ► Prävention / Gesundheitsförderung | |
| Technik ► Umwelttechnik / Biotechnologie | |
| Wirtschaft | |
| ISBN-10 | 0-08-101417-1 / 0081014171 |
| ISBN-13 | 978-0-08-101417-2 / 9780081014172 |
| Zustand | Neuware |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
| Haben Sie eine Frage zum Produkt? |
aus dem Bereich
