On 29 June, ROADMAP Consortium representatives from NICE, Biogen, Eli Lilly and Novartis went to London for an ITF briefing meeting held at the European Medicines Agency (EMA) to discuss ROADMAP’s activities.
What is EMA’s Innovation Task Force?
The ITF is a multidisciplinary group that includes scientific, regulatory and legal competences. It was set up to ensure coordination across the Agency and to provide a forum for early dialogue with applicants on innovative aspects in medicines development.
Why are ITF briefing meetings organised?
ITF briefing meetings provide a forum for early dialogue on medicines innovation. They cover regulatory, technical and scientific issues arising from innovative medicines development, new technologies and borderline products – but ITF briefing meetings are intended to be much earlier than when one would normally seek scientific advice.
ITF briefing meetings facilitate informal exchange of information and guidance in the development process, complementing and reinforcing existing formal procedures such as advanced-therapy-medicinal-product (ATMP) classification and certification, designation of orphan medicinal products and scientific advice.
The objectives are two-fold: firstly, for EMA to help clarify questions regarding the road to market of innovative medicines and secondly, to help ensure EMA awareness and preparedness for assessment of the most recent developments in innovative medicine.
The informal scientific brainstorming-discussions are led by experts from the Agency network, working parties and committees.
Read more about innovation in medicines.