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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)
New Approaches to Benefit/Risk Management Planning in the EU
Sabine Straus, MD, PhD, MSc
Medicines Evaluation Board (MEB), Netherlands
PRAC Chair, Staff Member
Innovative Industry Experience Since 2012 and Reflections on New EU Guidance
Valerie E. Simmons, MD, FFPM
Eli Lilly and Company Ltd, United Kingdom
Senior Medical Fellow, Global Patient Safety
Generics Industry Experience since 2012 and Reflections on New EU Guidance
Katarina Nedog, MSc
EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium
Associate Director
Panel discussion
June Raine, MD, MSc, FRCP
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Chief Executive
Panel Discussion
Peter Bachmann
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Deputy-Head, European Union and International Affairs
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