In response to an open call for tender, DIA (founded as the Drug Information Association) was awarded a service concession contract by the European Medicines Agency (EMA, the Agency) for the organization of a number of meetings and trainings during 2017-2020. EMA opened this concession for public bidding in 2016 for an “economic operator for the delivery of professional, large-scale, face-to-face meeting and training programmes tailored towards specific learning objectives” within the EMA’s areas of activity.

“DIA is honored to receive this EMA Service Concession for organising meetings and trainings on behalf of the Agency. This underscores DIA’s trusted reputation and strategic vision of facilitating productive relationships between key health care stakeholders, and delivering resources that help organisations stay at the forefront of the regulatory arena.”

Holger G. Adelman, MD, PhD, Senior Vice President & Managing Director, DIA EMEA

As a non-profit organisation, DIA will support the EMA with their duty in capacity building of national competent authorities in working with the new EudraVigilance system. Courses in support of the new system will begin in June 2017, with more than 20 offerings scheduled. The objective is to ensure both regulators and commercial stakeholders are well prepared when the new system launches in November 2017. Trainings also include the new ISO/ICH Individual Case Safety Report requirements and explanations on how to access the EudraVigilance Data in EVDAS and EVWEB. Additionally, DIA will support the Agency in organising important Information Days, including Signal Management.

Within the contract scope is to develop a new one-day workshop for statisticians to discuss designing and conducting both pre- and post-approval research and additional hot topics. Future events in additional activity areas, such as clinical trials and clinical data, master data management, and support with future capacity building needs, are also being explored.

Scheduled 2017 EMA Meeting and Trainings include:

• NEW EudraVigilance System trainings and the electronic reporting of ICSRs in the ISO/ICH E2B (R3) format starting in June 2017
• 2017 Information Days: EudraVigilance Information Day – 7 June
• 2017 Information Days: Signal Management Information Day – 27 October
• 2017 Information Days: Information Day on Measuring the Impact of Pharmacovigilance Activities – 14 November
• EU Statistics Forum – 1 December Call for Abstracts now open

More meetings on the horizon. Full 2017 Event Calendar will be published at the end of April 2017.