DDR (Barcelona, ES; London, UK) and Kinesys Consulting (Glasgow & London, UK) are pleased to announce that they 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.
EMA Solutions’ expert team also conducts Independent Scientific Advice assessments for clients when time, resources or other issues make approaching EMA or national agencies difficult.
Gerry McGettigan, EMA Solutions Director and CEO at Kinesys Consulting: “We are pleased and excited to announce the launch of EMA Solutions. Our mission is to help product developers globally to be ready to overcome key, challenging interactions with the European Medicines Agency and its committees.”
Xavier Luria, MD, EMA Solutions Director and CEO at DDR: “We have been delighted with the positive responses to our initiative, with both existing partners and new contacts signing up for our unique approach, thus recognising the value of the EMA Solutions platform.”