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Overview on International regulatory and pharmacovigilance conference “Croatian mark in the EU”


The international regulatory and pharmacovigilance conference "Croatian mark in the EU”, was organised from 11 to 12 November in Šibenik by the Agency for Medicinal Products and Medical Devices (HALMED), under the auspices of the Croatian Ministry of Health. The conference was aimed at informing all stakeholders on medicines regulations that came into effect after Croatia’s accession to the EU with the aim to better harmonise with these requirements. A round table on counterfeit medicines and introduction of safety features was also held within the conference.

Opening speeches at the conference were held by Viola Macolić Šarinić, MD, PhD, the Head of HALMED and Mr Nikica Penđer, Deputy Mayor of the City of Šibenik.

After the opening ceremony, the Head of HALMED and Division and Department Heads in a number of lectures presented HALMED’s achievements and novelties in the field of medicines and medical devices in the period after the EU accession. After presenting a general news overview an overview in the field of medicines authorisation, medicines and medical devices distribution, quality control and pharmacovigilance was also given. Also, results were also presented how HALMED answered to feedback and evaluation marks received from its clients with the aim to continuously improve the co-operation with its stakeholders and to improve the business operations.

Afterwards, HALMED staff members presented topics on Good Manufacturing Practice (GMP), HALMED’s experiences in pharmacovigilance inspection (GVP), news in GVP modules after the EU accession and education material

A round table "Counterfeit medicines and safety features”, was also held at the end of the first conference day, where positions on ever growing global problem of counterfeit medicines and implementation of safety features were presented by representatives of healthcare professionals, pharmaceutical industry, retail, wholesale, patient advocacy groups, Ministry of Health, Customs Office of the Ministry of Finance, Croatian Health Insurance Fund and HALMED.

The second conference day was intended to scientific topics in pharmacovigilance and biosimilar medicines. Alongside HALMED experts, presentations were also held by eminent European experts in medicines:

  • Dr Irene Rager, European Medicines Agency (EMA)
  • Mr Mick Foy, Medicines and Healthcare Regulatory Agency (MHRA)
  • Dr David J. Lewis, Novartis Pharma AG
  • Dr Ana Hidalgo-Simon, European Medicines Agency (EMA)
  • Ms María Luisa García-Vaquero, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).

The conference gathered some two hundred and fifty participants from healthcare professional, doctors, pharmacists, representatives from public health authorities, pharmaceutical industry, patients and media. Representatives of the competent authorities from Bosnia and Herzegovina, Montenegro, Kosovo, Makedonia and Serbia were also present at the conference.