“Introduction to Clinical Research and Principles of Good Clinical Practice” Workshop
Organized by
Association for Good Clinical Practice and Clinical Research Development (AGCPCRD)
www.agcp-crd.org
Drug Agency, Republic of Srpska
www.al.rs.ba
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.
www.comac-medical.com
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
