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Organising and initiating clinical studies is highly complex. This is even more difficult with trials investigating advanced therapies. The pathway to obtain regulatory, GMO and ethical permission to commence studies with ATMPs can be challenging. Identifying suitable sites for studies that can accommodate the requirements for the administration of ATMPs may also be difficult. These trials also have challenging designs incorporating potential long-term follow-up for regulatory and reimbursement purposes.

This event is a chance  for industry and healthcare providers to come together and look at their respective requirements in addressing the challenging issues in setup and running ATMP clinical trials. The agenda is focused on how to accelerate these processes in conjunction with the supporting government and regulatory bodies.

This meeting will create an opportunity to:

  • shape the landscape for the running of ATMPs clinical trials in the UK,
  • identifying gaps and barriers
  • providing some suitable solutions.

The day will feature a number of talks, case studies, panel discussions and smaller breakout sessions  to address detailed elements and make recommendations to assist study sponsors and clinical sites. This event will provide first-hand information from research, regulatory and commissioning bodies to support successful development of novel therapies with insights from industry perspectives.