The UNICOM project is gaining momentum rapidly. On January 14-15, a F2F workshop uniting experts from national medicinal products authorities was hosted by the Austrian Agency for Health and Food Safety Ltd. (AGES) in Vienna. About 20 experts from 13 consortium partners representing their respective national competent authorities (NCAs) as well as the project coordinator assembled.
The 2-day event was opened by the head of AGES Medicines & Medical Devices business segment, Dr. Christa Wirthumer-Hoche. She very much lauded the participating countries’ decision to join UNICOM and the strong impetus this project will provide for an accelerated implementation of IDMP standards across the European Union and beyond. And she underlined the strong support these efforts are receiving through UNICOM funding from the European Commission, for which she and her colleagues in other countries are very grateful.
The workshop allowed partners to meet face-to-face, exchange ideas and get to know each other better. Topics on the agenda included a first analysis of needs, objectives, resulting tasks as well as dependencies between involved NCAs. Initial plans and roadmaps were agreed upon. A core task of UNICOM concerns the development and testing of a pan-European IDMP compliant electronic form for the submission of marketing authorisation applications for newly developed medicinal products by the pharmaceutical industry. A focus of discussions was on necessary prerequisites to design, develop and later implement this Common EU Submission Platform (CESP). On day 2, experts discussed in greater detail initial common steps to be taken for further implementation of IDMP standards and code systems in national medicinal products data bases, how to coordinate these steps and learn from each other’s experience – lessons learned to be also disseminated to non-participating NCAs at a later stage.
Close attention was paid also to interdependencies with other work packages of the project and their impact on own work processes. These will be further explored at the upcoming face-to-face kick-off meeting of the whole consortium that will take place on 6-7 February 2020 in Bonn, Germany. Coordination across all work packages will be a key topic there.