News and Educations

The regulatory and pharmacovigilance workshop “With HALMED to keep up with the EU” is now open for registrations


The Agency for Medicinal Products and Medical Devices (HALMED) organises, in collaboration with the Croatian Pharmaceutical Society (HFD) the regulatory and pharmacovigilance conference entitled "With HALMED to keep up with the EU” that will be held from 6 to 7 December 2012 in the Hotel International in Zagreb.

Date and venue: 6 and 7 December, 2012, Hotel International, Zagreb


Regulatory Affairs:

  • Croatian accession to the EU:
    • Medicinal products authorised via mutual recognition (MRP), decentralised (DCP) and national procedure (NP)
    • Medicinal products authorised via centralised procedure (CP)
    • PALC III
    • Dossier upgrading
    • Frequently asked questions on regulatory affairs
    • What are the challenges after the accession ?


  • PSUR (new format, periodicity, procedures before and the accession, PSUR for generics…)
  • RMP (implementation of risk minimisation measures, variations…)
  • Volume 9A vs. GVP Module (what’s new, what modules are in effect, is there any change for Croatia…)
  • Spontaneous reporting of ADRs, EudraVigilance, literature reporting, electronic reporting - before and after the accession
  • The pharmacovigilance system master file - what will change in Croatia ?
  • Patient reporting of ADRs
  • QP for pharmacovigilance - before and after the accession
  • New pharmacovigilance legislation

The conference is intended for marketing authorisation holders in the Republic of Croatia (experts in regulatory affairs and pharmacovigilance, in particular), pharmacists, clinical pharmacologists, competent authorities for medicines and QPs for pharmacovigilance.

Detailed programme of the conference will be available soon.


We would kindly ask you to send the fulfilled registration forms electronically no later than 29 November, 2012 to Mr Armano Rajh ( or by fax at +385 1 4884 119.

Registration form (.doc); (.pdf)

Since the number of participants is limited, we kindly ask you to register early.

Registration fee

  • for marketing authorisation holders: 2000,00 kn +TVA = 2500,00 kn
  • for health care professionals, academia, competent authorities: 800,00 kn + TVA = 1000 kn

The registration fee includes networking lunches, coffee breaks and a conference dinner.

Fee payment

After application, the fee payment will be executed exclusively via a pro-forma invoice that will be delivered to participants via courier or fax according to the addresses listed in the registration form (the address where the pro-forma invoice is to be sent, should be indicated in the registration form).

Please submit a copy of the money order no later than 1 December 2012 to Mr Armano Rajh, via e-mail ( or fax +385 1 4884 119.

Termination period

In case of inability to participate, the registered participant should inform Mr Armano Rajh no later than 1 December, 2012.

Cancellation of participation

In case of cancellation or absence, the following scale for fee calculation applies:

  • Before 1 December, 2012, the fee is entirely reimbursed
  • From 2 December to 5 December 2012, the organiser reserves the right of 30 % of the conference fee
  • Before 6 December, or in the case of absence, the organiser reserves the right of 100 % of the conference fee

Continuing education accreditation

The conference participation will be accredited for continuing education according to regulations of the Croatian Medical Chamber and Croatian Pharmaceutical Chamber.

Organisers do not take responsibility for injuries, losses or damages to participants.

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The regulatory and pharmacovigilance workshop “With HALMED to keep up with the EU” is now open for registrations