The international conference „EU28: science, medicines, health – a regulatory system fit for the future” held in Dubrovnik
The international conference "EU28: science, medicines, health - a regulatory system fit for the future” was held in the Dubrovnik Palace hotel in Dubrovnik on 6 and 7 May 2013. The conference was 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 the 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
In her opening speech, the Head of HALMED, Viola Macolić Šarinić, MD, PhD, stressed: "Our main goal so far has been to meet the high requirements of the Croatian legislation in the field of pharmaceuticals and medical devices and thereby protect the interest of patients, their health and safety at all times. We will continue to carry out those tasks with the same enthusiasm and commitment once Croatia has become part of the European Economic Area”.
After the opening ceremony, Viola Macolić Šarinić gave a lecture on HALMED's achievements in the preaccession period. Then followed a series of lectures about the pre-accession challenges for Croatia in the field of medicine regulation, which were given by: Anthony Humphreys from the EMA, Mislav Vučić from PLIVA, Stefano Soro from the European Commission, Anita Filipović Sučić and Maja Lovrek from HALMED and Vlatka Kartelo and Tatjana Ajhler Đuretek from Belupo.
The afternoon hours were dedicated to topics from the field of medicine regulation, and the lectures were given by Anthony Humphreys from the EMA and Peter Bachmann from the German Federal Institute for Drugs and Medical Devices. Then lectures in the field of pharmacovigilance followed, given by Franck Diafouka, Fergus Sweeney and Thomas Geodecke from the EMA and Michael Foy from the British Medicines and Healthcare Products Regulatory Agency, Jurica Ester from the Croatian Association of Renal Patients on Peritoneal dialysis and Marina Dimov Di Giusti from HALMED.
The second day of the conference began with lectures about functioning of the inspection in the EEA held by Fergus Sweeney from the EMA, Ana Boban from HALMED, Vesna Koblar from raPHARM and Belén Escribano from the Spanish Agency for Medicines.
The topic of the last series of lectures was the adjustment to telematic system of the EU, and the lecturers included Olivier Simeon from the EMA, Klaus Menges from German Federal Institute for Drugs and Medical Devices, Andrea Johnson from the British Medicines and Healthcare Products Regulatory Agency, Pieter Vankeerberghen from Belgian Federal Agency for Medicines and Health Products and Dubravka Sudić from HALMED.
The conference was attended by around 250 participants - representatives from civil services, the public sector and the pharmaceutical industry from the EU member states, Albania, Bosnia & Herzegovina, Montenegro, Macedonia, Serbia and Kosovo.
The conference was supported by the IPA programme of the European Commission (Instruments for Pre-Accession Assistance programme), which supports, among other things, the participation of candidate and potential candidate countries in the activities of the European Institutions. The aim of the conference was to provide overview of the European legislation on medicinal products and to initiate the exchange of knowledge, dialogue and cooperation between Croatian and European experts from competent authorities and the pharmaceutical industry in the field of medicine regulation.
This conference complements the previous EMA conferences held in 2007 in Split, 2008 in Rijeka and 2011 in Zagreb titled "Pharmaceutical legislation - Croatia’s road to the EU”, "The EU regulatory network - challenges and opportunities for Croatia” and "Improving patient safety in Europe”.
Presentations from the lectures are available here.