Therapeutic Risk Management of Medicines

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. Introduction2. Basic principles of therapeutic risk management3. The evolution of therapeutic risk management4. Risk management in the European Union5. Risk management in the United States6. Overview of risk management around the world7. Developing a safety specification and selecting risks8. Pharmacovigilance planning9. Assessing the need for risk minimisation10. Developing risk minimisation plans/risk mitigation strategies11. Evaluating the effectiveness of risk minimisation12. Implementing risk management activities13. Effective interactions with health authorities14. Development risk management plans15. Benefit-risk assessment and public communication16. The commercial importance of risk management and risk-sharing schemes17. Learnings from other types of risk management18. The outlook for therapeutic risk management

"...a must-have book for those working in the field of therapeutic risk management of medicines...very useful as a training book for new pharmacovigilance officers, but it is also useful for experienced staff…" --Drug Safety, Oct 2014