Module 6

04 October 2024

Early Dialogue – Innovation Task Force (1)

• Early points of contact for researchers, developers, regulators • ITF briefing meeting: informal, 90 min brainstorming, free of charge • Innovative medicines, novel methodologies, novel technologies, novel approaches • Prepare for next steps : scientific advice, novel methodologies qualification and MAA • Uncover the need for specialised expertise

Analysis of ITF meetings 2021-2022

16

An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

16

Early Dialogue – Innovation Task Force (2)

ITF questions 2021-2022

Examples of non clinical/clinical topics

• Regulators can provide references to specific scientific guidelines, regulatory documents • Experts can recommend other pathways : scientific advice, qualification • In most of the cases, actionable guidance can be provided

17

An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

17

9