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Understanding Important Risks and the Evolution to Benefit-Risk Management Planning
Session Chair(s)
Maia Uuskula
Head of the Bureau of Pharmacovigilance, State Agency of Medicines, Estonia
This session will discuss the revised EU benefit-risk management planning good pharmacovigilance practice (GVP) and the expectations of regulators, industry and users of medicines. It will cover what is and is not an important risk and provide case studies and examples.
Speaker(s)
Sabine Straus, MD, PhD, MSc
Former PRAC Chair, Medicines Evaluation Board (MEB), Netherlands
New Approaches to Benefit/Risk Management Planning in the EU
Valerie E. Simmons, MD, FFPM
Senior Medical Fellow, Global Patient Safety, Eli Lilly and Company Ltd, United Kingdom
Innovative Industry Experience Since 2012 and Reflections on New EU Guidance
Katarina Nedog, MSc
Associate Director, EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium
Generics Industry Experience since 2012 and Reflections on New EU Guidance
June Raine, MD, MSc, FRCP
Chief Executive, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Panel discussion
Peter Bachmann
Retired from Head International Liaison Office and Conferences, Executive Depart, Federal Institute for Drugs and Medical Devices (BfArM), Germany
Panel Discussion
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