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MINIMISING COSTS, HURDLES, AND DUPLICATION: HOW REGULATORS, PAYERS AND POLICY MAKERS MAY PROFIT FROM PPPS
Session Chair(s)
Hans-Georg Eichler, MD, MSC
Consulting Physician
Austrian Association of Social Security Bodies, Austria
Learning from the ‘real-life’ use of the regulatory system helps address future challenges. In this session we discuss the results of recent analyses of the pharmacovigilance systems, the paediatrics regulation and the conditional approval pathway.
Learning Objective : To give participants an overview of recent insights from regulatory science on three components the system: pharmacovigilance, paediatrics and the conditional approval pathway. To discuss, based on the results presented, the potential for learning within the regulatory system and to share views how this learning could be translated into action.
Speaker(s)
Policy Maker Perspectives from the IMI GetReal Project
Sarah Garner, PHD
World Health Organization, Denmark
Acting Program Manager, Access to Medicines and Health Products
Collaborative learning from the regulatory system of medicines. Recent results from the Escher project.
Andre Broekmans
TI Pharma, Netherlands
Director, Escher
PPP: Beyond Publication - From scientific collaboration to regulatory and medical practice and new business models
Magda Chlebus, MA
EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium
Executive Director, Science Policy & Regulatory Affairs