Innovation in Life Sciences

Thursday 25 September 2008 09:30 to 17:45

Participants

Confirmed Speakers and Panelists include:

  • Roy Alder, past Director of Policy at the Medicines and Healthcare products (sic) Agency
  • Fabienne Bartoli, Deputy Director General, Agence française de sécurité sanitaire des produits de santé (Afssaps)
  • Andrew Baum, Pharma Research Team, Morgan Stanley
  • David Body, Irwin Mitchell
  • Professor Sir Alasdair Breckenridge, CBE, Chairman, MHRA
  • Jeffrey Bucholtz, Department of Justice, USA
  • Alex Denoon, Clifford Chance
  • Dr Peter Feldschreiber, MHRA, 4 New Square
  • Sara Gourley, Sidley Austin LLP
  • Joseph Hetrick, Dechert
  • Dr Duncan Fairgrieve, British Institute of International and Comparative Law, 1 Crown Office Row
  • The Hon. Mr Justice Jackson
  • James Lawford - Davies, Clifford Chance
  • Professor Chris Mason, University College London
  • Dr Alexandra McConnell, Clifford Chance
  • Professor Mark Mildred, Nottingham Law School, Nottingham Trent University
  • Leigh-Ann Mulcahy, 4 New Square
  • Professor Munir Pirmohamed, NHS Chair of Pharmacogenetics, Department of Pharmacology, University of Liverpool
  • Nathalie Rampal Olmedo, European Medicines Agency
  • Alexandre Regniault, Simmons & Simmons
  • Helen Usmar, Director EMEA, Deputy EU Qualified Person for Pharmacovigilance, Stiefel Laboratories
  • Professor Kent Woods, CEO, MHRA.

Further speakers from science, legal academia, industry, French Medicines Regulator and UK House of Commons are to be confimed.

Topics:

  • Innovation in Science: What Innovative Research is and how it is Produced - the View from the Lab Bench
  • The Regulatory Response to Innovation: Policy Issues for Innovation Compared to Traditional Drugs
  • Industry and Innovation: Challenges for Industry
  • Using the Advanced Therapies Regulations to Facilitate Innovation
  • IP Challenges and Issues with Innovative Products and Therapies - Stem Cells Example
  • EU/US Comparison of Institutional Shifts in Regulators Necessary to Regulate Global Innovation and Lessons from Off-Label Use
  • The Precautionary Principle: its centrality and (mis)-Application in Regulatory Decision-Daking
  • Product Liability: Challenges to Innovation by Civil Liability Claims
  • Regulation and Liability Interplay: US Pre-emption Case Law and European Comparative Analysis
  • Socio-Political Implications: Future Policy-Making and Public Consultations

17.45 to 19.15 - Book Launch of OUP Book, The Law and Regulation of Medicines, edited by Dr Peter Feldschreiber.

This event will be followed by a dinner at The Travellers Club with the speakers and will cost £80 per person.

Please click here for a copy of the programme

This event is kindly sponsored by