The international conference on medicinal products regulation “EU28:science, medicines, health – a regulatory system fit for the future” started today in Dubrovnik
06.05.2013
The two-days international conference "EU28: science, medicines, health - a regulatory system fit for the future” was solemnly opened today. This conference has been jointly organised by the European Medicines Agency (EMA), the Agency for Medicinal Products and Medical Devices of the Republic of Croatia (HALMED), under the auspices of the President of the Republic of Croatia, Prof. Ivo Josipović, PhD, and the Ministry of Health of the Republic of Croatia.
During the opening ceremony, the audience was addressed by:
- Ms Viola Macolić Šarinić, MD, PhD, Clinical Pharmacologist and Toxicologist, Head of Agency (HALMED)
- Mr Andreas Pott, Deputy to the Executive Director of the EMA
- Mr Stefano Sorro, Head of Unit for Quality, Safety and Efficacy in the DG SANCO of the European Commission
- Professor Izet Aganović, MD, PhD, Envoy of the President of the Republic of Croatia
- Mr Luka Vončina, MD, MSc, Assistant Minister of Health, President of the HALMED’s Board
- Mr Andro Vlahušić, MD, MSc, Mayor of the City of Dubrovnik
The Head of HALMED, Viola Macolić Šarinić, MD, PhD, stressed in her opening speech: "Our main goal by now, has been to meet the high requirements of the Croatian legislation in the field of pharmaceuticals and medical devices and thereby, to protect the interest of patients, their health and safety at any moment. We will continue to carry out those tasks, with the same enthusiasm and commitment, after Croatia has become part of the European Economic Area”.
The conference has been supported by the IPA programme of the European Commission (Instrument for Pre-Accession Assistance programme), supporting, among others, the participation of candidate and potential candidate countries in the activities of European Institutions.
The conference was attended by about 250 participants - representatives from the civil service, public sector and pharmaceutical industry from EU Member States, Croatia, Albania, Bosnia & Herzegovina, Montenegro, Macedonia, Serbia and Kosovo under unscr 1244/99.
The objective of the conference was to provide an overview of the pharmaceutical legislation and initiate an information exchange, dialogue and co-operation between the Croatian and European experts from competent authorities and pharmaceutical industry in the field of medicines regulation. The conferences encompasses a number of scientific topics, such as: the pre-accession challenges for Croatia in the field of medicines regulation, current achievements of HALMED in the period before Croatia’s accession to the EU, European marketing authorisation procedures, new pharmacovigilance legislation, risk management plan in the pharmaceutical industry, functioning of the inspection in the EEA and telematic novelties.
This conference complements to the previously held EMA conferences, 2007 in Split ("Pharmaceutical legislation - Croatia’s road to the EU”), 2008 in Rijeka (EU regulatory network - challenges and opportunities for Croatia”), and 2011 in Zagreb ("Improving the patient safety in Europe”).
