Innovation Offices are set up both by some European National Agencies and by the European Medicines Agency (EMA). These multidisciplinary groups provide advice on scientific and regulatory matters arising from the development of innovative Drugs, New Technologies and Borderline Products.
Interaction with the Innovation Offices usually takes place in the form of meetings. The EMA offers Briefing Meetings (BM) through the Innovation Task Force (ITF). Various National Competent Authorities (NCA) also offer this sort of interaction.
The BM at the EMA and meetings with some NCAs are free of charge and represent a valuable option for an initial planning of the best regulatory pathway that will successfully bring products onto the market.
DDR has extensive experience in providing regulatory support to companies and academic groups during these meetings.
How can DDR help?
- DDR provides close regulatory support throughout the whole procedure. Every step is specifically assessed and suitable recommendations are given.
- DDR ensures appropriate operational arrangements and interactions with the relevant Agency to set up meetings.
- DDR’s expertise guarantees a discussion on the most important topics with the relevant Agency, thereby ensuring the best feedback to address the company’s concerns.
- DDR will contribute to the definition of the next steps and milestones, blending the Agency’s feedback with the company’s drug development planning.
- DDR’s network provides personalized support on any specific topic.