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Assessing the Benefits and Risks as the Basis of Benefit-Risk Management
Session Chair(s)
Tomas Salmonson, DrMed, PhD
, Critical Path Institute, Netherlands
An update will be given on benefit-risk management methodologies and approaches along the medicines life cycle including implementation of IMI PROTECT results, advanced therapies, long-term surveillance challenges, benefit-risk management of well-established products, and patients’ perspectives integration.
Speaker(s)
Tomas Salmonson, DrMed, PhD
, Critical Path Institute, Netherlands
Update on Regulatory use of Benefit-Risk Methodologies
Gopalan Narayanan, MD, FFPM, FRCP
Vice President, Disruptive Biologics, Voisin Consulting Life Sciences, United Kingdom
Advanced Therapies: Planning the Long Term Follow-Up?
Marion Daverveldt
Medical Affairs Associate, SGS Life Science Services, Belgium
Overcoming the Challenges of B/R Assessment for Established Products
Conny Berlin, MS
IMI PREFER Project Leader & Global Head, Quantitative Safety and Epidemiology, Novartis Pharma AG, Switzerland
Patient Perspective Elicitation as Integral Part of the Drug Development Dialogue with Regulatory Authorities and Other Decision Makers
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