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“Introduction to Clinical Research and Principles of Good Clinical Practice” Workshop

Organized by
Association for Good Clinical Practice and Clinical Research Development (AGCPCRD)
Drug Agency, Republic of Srpska
Ministry of Health and Social Welfare, Republic of Srpska

Under the Aegis of
Minister of Health and Social Welfare, Republic of Srpska

Sponsored by
Comac Medical Ltd.


Friday, 20 June 2008

8:30 – 9:30                         Workshop Registration

Session 1 Moderator:        Nikola Radovic, MD, Country Manager, Comac Medical, Belgrade, Serbia

9:30 – 9:45                          Welcome words and Workshop Opening
Dr. Milen Vrabevski, Chairman AGCPCRD, Sofia, Bulgaria
Prof. Dr. Ranko Skrbic, Minister of Health and Social Welfare, Banja Luka, Republic of Srpska

9:45 – 10:15                        Current status of Clinical Research in Republic of Srpska
                                    Mr sc. iur Nedeljko Milakovic, Central Ethics Committee, Banja Luka, Republic of Srpska

10:15 – 11:15                      Introduction to Clinical Research
Borislav Borisov, MD, PhD, ex-Executive director of BDA (1998 - 2004), Sofia, Bulgaria

11:15 – 11:30                      Coffee Break

11:30 – 12:30                      Ethical Concerns in Clinical Research and Human Subject Protection
Ivaylo Tsanev, MD, Director of Clinical Operations Department, Comac Medical Ltd., Sofia, Bulgaria

12:30 – 13:00                      Historical Overview and Current Ethical Aspects in conducting clinical trials in Republic of Srpska
Prof. Svijetlana Stoisavljevic-Satara, Local Ethics Committee CCBL, Banja Luka, Republic of Srpska

13:00 – 14:30                      Lunch Break

14:30 – 15:30                      Basic GCP terms
Borislav Borisov, MD, PhD, ex- Executive Director, BDA (1998- 2004), Sofia, Bulgaria

15:30 – 16:15                      Clinical Study Documents
Vasko Dinev, MD, CRA, Comac Medical Ltd., Sofia, Bulgaria

16:15 – 16:30                      Coffee Break

16:30 – 17:15                      Reporting Adverse Events during Clinical Trials
Rossitsa Kostadinova, MD, Clinical Trial Manager, Early Phase Studies Dept., Comac Medical Ltd., Sofia, Bulgaria

17:15 – 17:45                      Q & A Session

19:00                                 Networking Dinner, Hotel Bosna

Saturday, 21 June 2008

Session 2 Moderator:        DraganVeljkovic, MD, JCRA, ComacMedical, Belgrade, Serbia

9:00 – 9:45                          Monitoring Clinical Trials
NikolaRadovic, MD, CountryManager, ComacMedical, Belgrade, Serbia

9:45 – 10:15                        Experience of EC in Serbia
Branka Krunic, Attorney, Local Ethics Committee CCS, Belgrade, Serbia

10:15 – 10:45                      Regulatory Framework of Republic of Srpska
                                    Dragana Babic, MD, Drug Agency, Banja Luka, Republic of Srpska

10:45 – 11:15                      Important steps in Recruitment and Retention of Patients
Prof. Snjezana Popovic-Pejcic, Clinical Center Banja Luka, Republic of Srpska

11:15 – 11:45                      Panel discussion of current problems and challenges in conducting clinical trials on the Balkans

11:45 – 13:00                      Networking Lunch, National Theatre

End of Workshop



© 2002 AGCPCRD