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Risk Management Plan Effectiveness Studies (EU-RMP)
September 30, 2014
Tuesday, September 30, 2014
9:00 am, Eastern Daylight Time (New York, GMT-04:00)
2:00 pm, GMT Summer Time (London, GMT+01:00)
3:00 pm, Europe Summer Time (Brussels, GMT+02:00)
This webinar will discuss new European Medicines Agency (EMA) requirements for Risk Management Plan Effectiveness Studies (EU-RMP) and the most appropriate study designs to submit to the Pharmacovigilance Risk Assessment Committee (PRAC) for approval.
The European Medicines Agency (EMA) requires Risk Management Plans (EU-RMP) for products approved and marketed in the European Union. In late 2013 the EMA started to require additional detail on risk management plan effectiveness evaluation studies and approval of these studies by the Pharmacovigilance Risk Assessment Committee (PRAC)
Industry experts Dr. William C Maier and Dr Terri Madison with a combined 40+ years of industry experience will share their knowledge about assessment of risk management plans and practical strategies for successful implementation of these studies in Europe.
William C. Maier MPH PhD
Chief Scientific Officer and VP Epidemiology & Risk Management,
With over 20 years of experience in drug development and commercialization at pharmaceutical companies in Europe and the United States. He was previously Executive Director of Epidemiology at GlaxoSmithKline and Elan Pharmaceuticals and led research groups conducting observational research to support product registration, drug safety, post-marketing surveillance and risk management throughout the world. He routinely provides training seminars to medical products companies in Europe and the US on conduct of post-marketing surveillance studies, pharmacoepidemiology and risk management.
He is a member of the EMA’s European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (www.encepp.eu). In addition, he is a frequent speaker at medical conferences and has adjunct academic appointments in the UK (University of Dundee) and the USA (University of North Carolina).
Terri Madison, PhD, MPH
Vice President, Epidemiology & Risk Management,
An epidemiologist with over 25 years of experience using evidence-based science and risk management methods to reinforce the risk-benefit profile of biopharmaceutical products. Her previous industry roles include Vice President, Epidemiology and Risk Management at Xcenda, President of i3 Drug Safety, and Chief Operating Officer at STATPROBE, where her experience included providing strategic consulting services for several risk management and REMS programs, and helping manufacturers design and implement comprehensive safety surveillance studies to meet requirements of regulatory authorities including PASS and PMR studies. Dr. Madison is an industry expert in epidemiology, drug safety, and risk management. Her comprehensive understanding of the applicable regulations and guidance documents, and broad knowledge of existing risk management and safety surveillance programs across a variety of products and product classes, enables her to provide evidence-based strategic advice, while also understanding the critical importance of synergizing risk management and safety strategy with the overall value-driven commercial strategy to maximize appropriate patient access and product risk-benefit.
Dr. Madison received her PhD and MPH in Epidemiology from the University of Michigan. She was the recipient of a National Institutes of Health predoctoral fellowship in Cancer Training and Prevention from the School of Public Health's Departments of Environmental Health and Epidemiology.