Agency for Medicinal Products and Medical Devices of Croatia (HALMED) organized an international regulatory and pharmacovigilance conference “Croatian mark in the EU“ on 11th and 12th of November 2014 in Šibenik under the auspices of Ministry of Health of the Republic of Croatia. The conference was organized in order to inform all participants of the regulatory changes that occurred by Croatian access to the European Union, with the aim of achieving quality adjustment. A round table about counterfeit medicinal products and the implementation of safety labels was held at the conference.
HALMED achievements and news in the field of medicinal products and medical devices in the period of Croatian access to the European Union were presented, an overview was given on granting of Marketing Authorisation approvals, medicinal products and medical devices market, quality control and pharmacovigilance. There were lectures on Good Manufacturing Practice (GMP) inspection, HALMED experiences in pharmacovigilance inspection (GVP), news in GVP modules since EU accession and educational materials. The second day of conference was devoted to specialized topics in the field of pharmacovigilance and biosimilar medicines. Lectures were held by HALMED employees as well as respected European experts.
The conference brought together about 250 participants: representatives of regulatory authorities of Bosnia and Herzegovina, Montenegro, Kosovo, Macedonia and Serbia, healthcare professionals, doctors, pharmacists, representatives of Croatian public health authorities and pharmaceutical industry, patients and media.
Clinres’ employees attended this conference.