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Presentations from the 2017 conference

Personalised medicines and companion diagnostics in an evolving regulatory framework

Stephen Lee, Biosciences Team Manager, Devices Division, Medicines and Healthcare products Regulatory Agency
The new EU in vitro diagnostics medical devices regulation: overview and expectations for the approval of companion diagnostics

Dr Tom Lillie, Vice President, Head of European Clinical Development, MSD
Accelerating development and bringing to market of companion diagnostics in the context of personalised medicines

Enhanced support for the development of promising new medicines: PRIME one year on

Robert Hemmings, Manager, Licensing Division, Medicines and Healthcare products Regulatory Agency, Committee for Medicinal Products for Human Use (CHMP) member, and Chair, CHMP’s Scientific Advice Working Party, European Medicines Agency

Regulators Learning

Simon Bennett, Director, Regulatory Policy, EU and Global Emerging Markets, Biogen
Industry experience: Case study 2 – Aducanumab for Alzheimer’s disease 

Dr Matt Norton, Director of Policy and Strategy, Alzheimer’s Research UK
Research charity perspective