Industry stakeholder platform on research and development support

• Date:
  Terça, 25 Abril 2017, All day
• Localização:
  European Medicines Agency, Amsterdam, the Netherlands

This is the first event in a series of upcoming, (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

Agenda – Industry stakeholder platform on research and development support

Reference Number: EMA/88749/2017

Highlight report of the Industry stakeholder platform on research and development support (from the meeting on 25 April 2017)

Presentation - Regulatory HTA parallel scientific advice throughout the life-cycle of the product (Jane Moseley)

Presentation - Experience and opportunities for the co-development (process) of companion diagnostics and medicinal products (in the EU) (Falk Ehmann, Efthymios Manolis and Armin Ritzhaupt)

Presentation - Use of real world data in development programmes (Dr Alison Cave and Dr Francesca Cerreta)

Presentation - Optimising the guidance on significant benefit demonstration in the context of protocol assistance (Matthias Hofer)

Presentation - Implementation of the 2016 Notice on the application of the orphan regulation (Kristina Larsson)

Presentation - Early dialogue for paediatric development plans (Gunter Egger)

Presentation - Facilitating engagement with the FDA to allow shaping paediatric development programmes (Irmgard Eichler)