News and Educations

Workshop on variation procedures in Zagreb, Croatia


In a collaboration with the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) and representatives of pharmaceutical industry of Croatia, Medicademy - an international educational program established in 2002 by The Danish Association of the Pharmaceutical Industry (Lif) in collaboration with the University of Copenhagen and the Danish Medicines Agency - is organising a workshop on variation procedures, which will take place on 4 and 5 May 2017 in Zagreb, Croatia. The workshop, which will be held in English language, is open to all with an interest in the variation regulation, with emphasis on representatives of marketing authorisation holders (particularly those working in regulatory affairs) as well as representatives of competent authorities.

This workshop will address a number of the questions that marketing authorisation holders may have on variation procedures, with emphasis on the MRP, DCP and national procedure. The workshop will also provide an overview of the EU legislation concerning various types of variations. Moreover, it will include a session on work-sharing and grouping as well as on when to use these submission pathways. The workshop will have lecturers from various European authorities such as HALMED (Croatia) and BfArM (Germany) as well as the industry. Panel sessions and group work will contribute to an all-encompassing approach to various topics and ensure that the audience can take an active part in the debate and the sharing of experience.

Additional details on the workshop, including participation fees and the program, are available in the brochure as well as on the Medicademy website, through which those interested can also register for the participation in the workshop. Registration deadline is 15 March 2017.