Lectures dedicated to pharmaceutical regulatory affairs at the Fourth Croatian Congress on Pharmacy
Lectures dedicated to pharmaceutical regulatory affairs will take place on 27 and 29 May 2010 in Opatija, Hotel Ambasador, within the Regulatory Sciences Section of the Fourth Croatian Congress on Pharmacy with international participation.
The Congress will be held on 27-30 May 2010 in the Hotel Ambasador, in Opatija, organised by the Croatian Pharmaceutical Society (HFD) in cooperation with the Faculty of Pharmacy and Biochemistry of the University of Zagreb, and the Agency for Medicinal Products and Medical Devices.
The programme of Regulatory Affairs Lectures
Thursday, 27 May 2010; in the afternoon
Roundtable on expert and assessment reports on medicinal products
The roundtable discussion will bring together a representative of the Agency for Medicinal Products and Medical Devices and the representatives of the domestic and international pharmaceutical industry.
The official language of the Roundtable will be Croatian.
Saturday, 29 May 2010; in the morning
Lectures on regulatory affairs will include the following topics:
- Quality Assessment of Generic Medicines
- Regulatory Requirements in the Marketing Authorisation Procedure in Bosnia and Hercegovina and Serbia
- nCADREAC Procedure - Innovative Industry Perspective
- Regulatory Challenges for Generic Industry Today and Expectations for the Future
- The Anti-counterfeiting of Medicines
- Industry e-CTD Implementation
- Pharmacovigilance: the Role of the Regulatory Authority
- Pharmacovigilance-the Role of the Pharmaceutical Industry
The lectures will be given by the experts of the Agency for Medicinal Products and Medical Devices and the generic and research-based industry from Croatia and the neighbouring countries. The lectures will be in Croatian.
Programme of the Roundtable and Lectures on regulatory affairs is available from the link below:
Programme
Registration
Only registered participants of the Fourth Croatian Congress on Pharmacy will be able to attend the Regulatory Affairs Lectures. Information on how to register for the Congress may be found in the Pharmaceutical Journal (Farmaceutski Glasnik) and the website: www.hfd-fg.hr.
General information on the Congress:
The Croatian Pharmaceutical Society
Masarykova 2, 10 000 Zagreb
Phone:+385 (0)1 48 72 849; Fax: +385 (0)1 48 72 853
Information concerning the Regulatory Affairs Lectures:
Anita Filipović Sučić, PhD, MSc (Pharm)
Agencija za lijekove i medicinske proizvode 4, 10 000 Zagreb
Phone: +385 (0)1 4884 103; Fax: +385 (0)1 4884 110
e-mail: anita.filipovic@almp.hr
The organisers reserve the right to change the programme.
