Second industry stakeholder platform on research and development support

• Date:
  Wednesday, 15 November 2017, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This is the second event in a series of (semi-)annual meetings between regulators and representatives of industry stakeholder organisations. It addresses all areas of product development support, from scientific advice, over specifics for paediatric and orphan medicines and to innovation support. This platform aims to provide an opportunity for both general updates and more focused discussions on specific processes or issues to support continuous improvement, and generally to foster a constructive dialogue with industry stakeholders. Registration by invitation only.

Documents

Highlights report of the second industry stakeholder platform on research and development support

Reference Number: EMA/759581/2017

Agenda - Second industry stakeholder platform on research and development support

Reference Number: EMA/630645/2017

Presentation - The first experience with the newly launched Parallel Consultation platform (J. Moseley, EMA)

Presentation - The first experience with the newly launched Parallel Consultations (C. Guilhaume, EUnetTHA)

Presentation - Strengthening the prospective discussions on post-licensing evidence generation (J. Moseley, EMA)

Presentation - Recent update of the guidance for Parallel EMA/FDA scientific advice (T. Vetter, EMA)

Presentation - Publication of the Orphan Maintenance Assessment Report (K. Larsson, EMA)

Presentation - Continuous progress in the area of paediatrics (E. Desfontaine, EMA)

Presentation - A new way of managing procedures - Pilot for Orphan Medicine designation activities (V. Johnson, P. Tomasi, EMA)