DDR (Barcelona, ES; London, UK) and Kinesys Consulting (Glasgow & London, UK) have joined forces to create a unique platform of EU regulatory and scientific experts, EMA Solutions, with the aim of preparing and helping Applicants for interactions with the European Medicines Agency, in particular Oral Explanations (OE) at CHMP and other committees.
The team of experts at EMA Solutions is comprised of ex-CHMP, National Competent Authority and FDA Assessors, as well as seasoned industry experts. EMA Solutions’ experts have years of direct experience of OEs, seen from both inside the EMA and from the industry perspective. This experience will give clients a unique insight into the workings of CHMP and the best possible preparation for an OE. In particular, for a critical CHMP OE at Day 180 during the MAA, it is essential to have the right scientific/medical expertise and regulatory support, to have a clear and concise communication strategy, and to be prepared for the meeting room dynamics at EMA facilities. The experts at EMA Solutions are selected on a project-by-project basis to meet clients’ needs. Similarly, for interactions with COMP, PRAC and PDCO, the team’s experience is second to none, having worked successfully on a range of OEs.
We believe that it is not only important to have the right technical content, but also to convey your message effectively. Therefore, our service includes dissemination strategy and support so that you can reap the full rewards from generating the technical content for an OE, through clear and effective communication. This integrated approach is designed to give our clients the best chance of success at these critical timepoints.