CLIN-Net and LAB-Net GCP Training Balkans

On June 14 and 15, COMBACTE will offer its 6th Good Clinical Practice (GCP) training. This time, clinical and laboratory investigators from Albania, Kosovo, Macedonia and Montenegro will be invited. The event will take place in Podgorica, Montenegro.

In collaboration with partner European Forum of Good Clinical Practice (EFGCP), a 2-day program was developed. Expert trainer Dr. Ingrid Klingmann¹ from EFGCP and Dr. Annemarie van ‘t Veen² from LAB-Net are the trainers of the GCP training. The program consist of different exercises, clinical and laboratory break-out sessions and information about the most relevant GCP regulations. This in combination with practical guidance into optimizing the often so difficult recruitment of patients will support the performance of investigators in clinical trials. After these plenary sessions, the course will be finished with an official Transcelerated accredited exam. If the GCP exam is successfully passed, an official certificate will be provided.
The next face-to-face GCP training course will be held on 13th and 14th of September 2017, and will be organized for our COMBACTE investigators in Romania.

COMBACTE’s network in the Balkan countries consists of 25 hospitals and 44 laboratories (Albania: 8 hospitals and 9 laboratories, Kosovo: 4 hospitals and 5 laboratories, Macedonia: 5 hospitals and 20 laboratories, Montenegro: 8 hospitals and 10 laboratories) out of which hospitals have been selected to perform studies such as EURECA. Previously held COMBACTE face-to-face GCP trainings were in Sofia, Grindelwald, Madrid, Belgrade and Athens.

¹Ingrid Klingmann (MD, PhD, FFPM, FBCPM, PHARMAPLEX bvba European Forum for Good Clinical Practice, Brussels (Belgium)) is Chairman of the Board of the European Forum for Good Clinical Practice (EFGCP). On behalf of EFGCP she was Work Package Leader of the PatientPartner Project and is currently Coordinator of the IMI project PharmaTrain. She is Work Package Leader of EUPATI, responsible for developing the EUPATI Network, the EUPATI National Platforms and the Ethics Panel. Dr. Klingmann chairs the clinical research module of the post-graduate Master in Regulatory Affairs course at the University of Bonn, Germany, and co-chairs the Diploma Course in Clinical Trial Practices at the University of Basel, Switzerland.

²Annemarie van ’t Veen (MD, PhD, MBA) works as a clinical microbiologist in the University Medical Centre in Utrecht, The Netherlands. She has been actively involved in building quality systems (ISO15189, GCP, Hospital Patient Safety program) in microbiology laboratories and hospitals in the Netherlands. Annemarie is member of the COMBACTE LAB-Net team and works on developing a quality assurance program in the LAB-Net network.