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Assessing the Benefits and Risks as the Basis of Benefit-Risk Management
Session Chair(s)
Tomas Salmonson, DrMed, PhD
Partner
Critical Path Institute, United States
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)
Update on Regulatory use of Benefit-Risk Methodologies
Tomas Salmonson, DrMed, PhD
Critical Path Institute, United States
Partner
Advanced Therapies: Planning the Long Term Follow-Up?
Gopalan Narayanan, MD, FFPM, FRCP
Voisin Consulting Life Sciences, United Kingdom
Vice President, Disruptive Biologics
Overcoming the Challenges of B/R Assessment for Established Products
Marion Daverveldt
SGS Life Science Services, Belgium
Medical Affairs Associate
Patient Perspective Elicitation as Integral Part of the Drug Development Dialogue with Regulatory Authorities and Other Decision Makers
Conny Berlin, MS
Novartis Pharma AG, Switzerland
IMI PREFER Project Leader & Global Head, Quantitative Safety and Epidemiology
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