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09.00 - 09.30

Registration, refreshments and networking

09.30 - 09.40

Welcome and Introduction from the Co-Chairs

Dr Ian Hudson
Chief Executive, Medicines and Healthcare products Regulatory Agency

Alan Morrison
Chairman, BIA Regulatory Affairs Advisory Committee, and Vice President, Regulatory Affairs International, MSD

09.40 - 10.50

Accelerated Access Review recommendations and the Life Sciences Industrial Strategy

09.40 - 10.10

Taking medicines through regulatory approval, health technology assessment and faster adoption of innovative healthcare across the NHS for the benefit of patients

Keynote address:
Simon Stevens
Chief Executive Officer, NHS England

10.10 - 10.50

Panel Discussion/Q&A including:

Dr Ian Hudson
Chief Executive, Medicines and Healthcare products Regulatory Agency

Jessamy Baird
Director of Patient Access, Sanofi

Sir Andrew Dillon
Chief Executive, National Institute for Health and Care Excellence

Hilary Newiss
Chair, National Voices

Dr Luisa Stewart
Deputy Director for Innovation, Office for Life Sciences

10.50 - 11.20

Refreshments and networking

11.20 - 12.30

Personalised medicines and companion diagnostics in an evolving regulatory framework 

11.20 - 11.50

The new EU in vitro diagnostic medical devices regulation: overview and expectation for the approval of companion diagnostics

Stephen Lee
Biosciences Team Manager, Devices Division, Medicines and Healthcare products Regulatory Agency 

11.50 - 12.20

Accelerating development and bringing to market of companion diagnostics in the context of personalised medicines

Dr Tom Lillie
Vice President, Head of European Clinical Development, MSD

12.20 - 12.30

Q&A

12.30 - 12.50

Keynote address - the future of medicines regulation

Lord O'Shaughnessy
Parliamentary Under Secretary of State for Health

12.50 - 14.00

Lunch and networking

14.00 - 15.00

Panel Discussion/Q&A

Implications of the EU Referendum outcome: Practicalities, challenges and opportunities

Steve Bates OBE
Chief Executive Officer, BIA, and UK-EU Life Sciences Steering Group

Andrew Gregory
Deputy Director, Policy Division, Medicines and Healthcare products Regulatory Agency

Dr Paul Huckle
Chief Regulatory Officer, GlaxoSmithKline

Alan Morrison
Chairman, BIA Regulatory Affairs Advisory Committee, and Vice President, Regulatory Affairs International, MSD

15.00- 15.30

Refreshments and networking

15.30 - 16.50

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

15.30 - 15.50

Regulators Learning

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

15.50 - 16.05

Industry experience: Case study 1 - Gene therapy for the treatment of haemophilia A 
Chay Morgan
Head of EU Regulatory Affairs, BioMarin

16.05 - 16.20

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

16.20 - 16.35

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

16.35 - 16.50

Panel discussion / Q&A

16.50 – 18:00

Networking drinks reception