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Benefit-Risk Management Planning through the Life Cycle of a Product
Session Chair(s)
Robert Hemmings, MSc
, Critical Path Institute, Netherlands
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)
Robert Hemmings, MSc
, Critical Path Institute, Netherlands
Initiatives to Enhance the Development and Regulation of Medicines – Before and After Marketing Authorisation
Wim Goettsch, PhD, MSc
Special Advisor HTA, Dutch National Health Care Institute (ZIN), Netherlands
How Can Real-World Data Support Decisions on Early Reimbursement of New Technologies?
Chris Burke, MSc
Risk Based Monitoring Product Specialist , Medidata Solutions, United Kingdom
The Age of Big Data and Better Analytics: How to Achieve Operational and Clinical Gains
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