HALMED in the company of prominent representatives of the European regulatory network
The Head of the Agency for Medicinal Products and Medical Devices (HALMED), Viola Macolić Šarinić, MD, PhD, participated today together with prominent representatives of relevant European medicines authorities at the round table discussion within the Conference "Different perspectives - one vision; better patient health protection”, organised by Drug Information Association (DIA) from 25 to 27 March 2014 in Vienna.
The round table with the main discussion topics like the transparency, implementation of pharmacovigilance legislation, recent changes in clinical trials legislation, innovative medicines and Croatian accession to the EU were chaired by the Executive Director of the European Medicines Agency (EMA), Guido Rasi, and the Head of the Austrian Medicines and Medical Devices Agency (AGES), Christa Wirthumer-Hoche. Among other representatives from the relevant EU competent authorities of the medicines regulatory network who participated together with the Head of HALMED were: the Chair of the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), June Raine , the representative of the Directorate General for Health and Consumer Protection (DG SANCO),Andrzej Ryś, the Chair of the Committee for Human Medicinal Products, Tomas Salmonson, and the President of the Federal Institute for Medicines and Medical Devices (BfArM), Walter Schwerdtfeger.
In addition to participating in the round table discussion, the Head of HALMED held a lecture on challenges and current achievements after Croatian accession to the EU. During the Conference HALMED as a competent regulatory authority of a Member State received many compliments from prominent participants with regard to the successful integration to EU marketing authorisation procedures and undertaking responsibilities and obligations as a full member of the EU regulatory network for medicines. Also, the leading pharmacovigilance actors emphasised the amazing Croatian pharmacovigilance experience, as well as the HALMED’s proactive approach in surveillance of safe use of medicines.