Integrated Scientific Advice in Product Development to Accelerate Patient Access


6th November, 2017
Time: 08:30 - 18:00

Location: Glasgow, Scotland
Timezone: (GMT -5:00) Eastern Time (US & Canada), Bogota, Lima

Presenters:

Dr. Matthew Bending
Mr. Rory Graham
Dr. Amina Udechuku
Dr. Sabine Latour
Dr. Jacoline Bouvy
Mr. Guy Sherwin

On November 6th 2017, during the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Congress in Glasgow, ICON and Mapi hosted an expert-led workshop to discuss multi-stakeholder perspectives of the value of early engagement.

The workshop, “Early Integrated Scientific Advice in Product Development: Get Real and Adapt to Accelerate Patient Access” was well attended by industry experts. The shifting regulatory and HTA paradigm was discussed, as well as the opportunities and challenges of a number of regulatory and HTA initiatives designed to support companies in managing this shifting paradigm, with the aim of improving patient access to innovative new medicines. The initiatives discussed included:

  • Enhanced scientific advice within the European Medicines Agency (EMA) Priority Medicines (PRIME) initiative
  • Integrated regulatory and HTA scientific advice with a focus on the EMA/EUnetHTA Parallel Consultation process introduced in July 2017
  • The Adaptive Pathways concept from a regulatory, HTA, and industry perspective
  • The continuously evolving use of outcomes-based and contracting agreements

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