Eight industry stakeholder platform on research and development support

• Date:
  Monday, 11 July 2022, All day
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

This is the eighth in a series of regular meetings between regulators and representatives of industry stakeholder organisations. It addresses all areas of evidence generation along the medicine’s life-cycle and related to development support activities, such as scientific advice and qualification, as well as specifics for paediatric and orphan medicines.

This meeting will focus on strengthening the ecosystem of engagement platforms for evidence planning, continuous improvement of paediatric procedures, patient-centric development, collaboration at the regulatory/HTA interface, follow-up from the 5-year report on the experience with the PRIME scheme, actions following the “Orphan Maintenance Assessment Report” survey as well as progress with the implementation of the companion diagnostics framework.

Documents

Agenda - Eight industry stakeholder platform on research and development support

Presentation - Status update in terms of scientific advice capacity and development of proposals moving forward (Iordanis Gravanis)

Presentation - Repurposing pilot project: Update and first insights (Christelle Bouygues, Anna Tavridou)

Presentation - Experience with the ITF framework for 3Rs and new approach methodologies (NAMs)

Presentation - Report from the focus group on the practical application of principles relevant for the paediatric investigation plan (PIP) framework (Chrissi Pallidis, Gesine Bejeuhr)

Presentation - Status of paediatric investigation plan (PIP) compliance check procedure (Peter Karolyi)

Presentation - Multi-stakeholder workshop: Patient experience data in medicines development and regulatory decision-making (Nathalie Bere)

Presentation - Collaboration at the regulatory/HTA interface Progressing parallel Joint Scientific Consultations: Experience from the first call and preparation of the second one (Antje Behring,Thorsten Olski)

Presentation - PRIME: Implementation of recommendations based on first 5 years’ experience with the scheme (Stefanie Prilla)

Presentation - Outcomes of the EMA Survey on Orphan Maintenance Assessment Reports (OMARs) (Kristina Larsson)

Presentation - Progress with the implementation of the companion diagnostics framework under the EU In-vitro diagnostic Regulation (IVDR) (Ana Trullas, Ciska Verbaanderd)

Minutes - Highlight report from the 8th Industry stakeholder platform on research and development support

Reference Number: EMA/644334/2021