Third industry stakeholder platform on research and development support

• Date:
  Friday, 18 May 2018, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, 'histology-independent indications' in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine development programmes, co-development with companion diagnostics and cross-decision maker collaboration in the space of horizon scanning activities. It also provides an opportunity for updates on post-authorisation evidence generation activities, paediatric medicines and the PRIME scheme.

Documents

Minutes - Third industry stakeholder platform on research and development support

Reference Number: EMA/365499/2018

Agenda - Third industry stakeholder platform on research and development support

Reference Number: EMA/195267/2018

Presentation - Experience with the review of the orphan designation in the context of extension of indication (Kristina Larsson)

Presentation - Histology-independent indications (Kristina Larsson)

Presentation - Targeting “histology-independent indications” and resulting challenges in the context of orphan designations (Francesco Pignatti)

Presentation - Scientific and regulatory evaluation procedure support [S-REPS] pilot update / system preview (Sylvie Beausuroy, Paolo Tomasi, Bob Coggins)

Presentation - EMA experience with the review of digital technology proposals in medicine development programmes (Francesca Cerreta)

Presentation - Evolving framework for the co-development of medicinal products with companion diagnostics (Falk Ehmann and Armin Ritzhaupt)

Presentation - Understanding which technologies are coming into the healthcare systems (Michael Berntgen)

Presentation - Post licensing evidence generation (PLEG) (Jane Moseley)

Presentation - Follow-up from the EC/EMA workshop on paediatrics (Ralph Bax)

Presentation - Update on PRIME (Jordi Llinares and Zahra Hanaizi)