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Benefit-Risk Management Planning through the Life Cycle of a Product
Session Chair(s)
Robert Hemmings, MSc
Partner
Critical Path Institute, United States
This session will aim to introduce and frame not only the subsequent sessions in the Benefit-Risk Management Theme but also links to the evolutions to be presented and discussed in the Innovation, eHealth/Big Data, and HTA themes. Multiple scientific and policy initiatives have the potential to change the landscape for drug discovery, development, regulation, and reimbursement. The session will present some highlights, with a particular focus on optimising drug development, real-world and ‘big’ data, and multi-stakeholder dialogue, to inform prospective planning for evidence generation across the drug life cycle.
Learning Objective : Define: what is big data and how can it support clinical researchers? How to use big data in study planning and conduct Lessons learnt: metrics, benchmarks, and data visualizations that work
Speaker(s)
Initiatives to Enhance the Development and Regulation of Medicines – Before and After Marketing Authorisation
Robert Hemmings, MSc
Critical Path Institute, United States
Partner
How Can Real-World Data Support Decisions on Early Reimbursement of New Technologies?
Wim Goettsch, PhD, MSc
Dutch National Health Care Institute (ZIN), Netherlands
Special Advisor HTA
The Age of Big Data and Better Analytics: How to Achieve Operational and Clinical Gains
Chris Burke, MSc
Medidata Solutions, United Kingdom
Risk Based Monitoring Product Specialist
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