Opportunities and challenges in the regulation of healthcare innovation

Opportunities and challenges in the regulation of healthcare innovation

Date: June 19, 2014

Location: Euston Square, London

Registration is now open for the fourth joint BIA and MHRA conference – Opportunities and challenges in the regulation of healthcare innovation taking place on Thursday 19 June at 30 Euston Square, London.
This one-day conference will give insights into the opportunities and challenges in the regulation of healthcare innovation. Taking advantage of existing regulatory flexibilities in EU legislation can enhance the environment for developing innovative medicines, including personalised medicines and advanced therapies. Engagement between regulators and those developing medicines is crucial to foster innovation and accelerate patient access
Co-chaired by Dr Ian Hudson, Chief Executive Officer, MHRA, and Alan Morrison, Vice President, International Regulatory Affairs and Safety, Amgen and Chairman, BIA Regulatory Affairs Advisory Committee, this conference will be the ideal place to hear the latest thinking from senior experts at MHRA, NICE, European regulatory agencies, industry and research charities in one central London location.
Programme includes:

  • The Expert Group on Innovation in the Regulation of Healthcare: Summary of recommendations and next steps
  • Using existing regulatory flexibilities: Kalydeco for the treatment of cystic fibrosis
  • The EMA’s Innovation Task Force: Update on new and emerging therapies and technologies
  • The MHRA’s Innovation Office: One year on
  • Parallel scientific advice with regulators and health technology assessment bodies
  • Cancer Research UK Stratified Medicine initiative
  • Regulatory tools to support the development and licensing of personalised medicines
  • Industry experience with personalised medicines: Lessons learnt
  • Health technology assessment of personalised medicines and companion diagnostics
  • Scientific and regulatory considerations for advanced therapy medicinal products: Where are we today and where are we going
  • Sponsor’s perspective on conducting a cell therapy trial
  • Manufacturing challenges for advanced therapy medicinal products

To register or for more information on this must-attend conference please click here or contact Cathrine Smyth.