The Association for Good Clinical Practise and Clinical Research Development was founded in April and registered in June 2002, in Sofia, Bulgaria. The Association is the first Bulgarian non-profit legal entity engaged in activities in the field of Good Clinical Practice and clinical research to be of public professional interest. These activities include: training of medical personnel for participation in international research and development projects on the territory of Bulgaria and the Balkan countries ensuring Good Clinical Practice (GCP) compliance as well as opening and coordinating professional public discussions aiming to improve local legislation in compliance of the applicable directives in the European Union. The Association is aiming to contribute in a direct manner to the promotion of good governance in the medical field.
The Association for Good Clinical Practise and Clinical Research Development is chaired by Milen Vrabevski, MD – founder and CEO of COMAC MEDICAL.
CDISC European Roadshow – Sofia Feb 2009
The Association for Good Clinical Practice and Clinical Research Development is a sponsor and organizer of the first educational workshop in Eastern Europe – CDISC European Educational Roadshow, Sofia/Bulgaria. The seminar was opened by Mrs. Yordanka Fandakova, Deputy Mayor of Sofia – at the Grand Hotel Sofia on Thursday 19th February 2009.
The event, organized in association with the Clinical Data Interchange Standards Consortium (CDISC), aims to provide to clinical research specialists and regulatory authorities from the Balkan countries good adoption and compliance with the global standards for acquisition, exchange, submission and archive of clinical research data and metadata. The main objective is to raise delegates’ awareness of the purposes of each standard of how they might positively impact their own research and development operations. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. The European Medicines Agency (EMEA) recognizes the leading role of CDISC in Europe and regularly requires CDISC participation in technical advisory committees.
The event emphasizes the serious intent of the Balkans to become truly leaders in aggregation and processing of clinical data and as well the coordinating role for the region of the Bulgarian research and development organizations in compliance with the Seventh Framework Program of the EU for development of knowledge-based economy.
Introduction to Clinical Research and GCP – Banya Luka, Jun 2008
“Introduction to Clinical Research and Principles of Good Clinical Practice” workshop was organized in Banya Luka, Bosnia and Herzegovina with the general sponsorship of COMAC MEDICAL. The purpose of the workshop was to offer valuable professional cross-functional learning, networking experiences, and continuing education opportunities for the health care professionals. The event was co-organized by the Association for Good Clinical Practice and Clinical Research Development, Drug Agency of Bosnia and Herzegovina and Ministry of Health and Social Welfare, Bosnia and Herzegovina.
The seminar agenda focused on important issues in medical ethics and industry-academia partnership involvement: recognizing the importance of Good Clinical Practice (GCP) as an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve human participants; adhering to the rules of good clinical practice (GCP) as a shared responsibility in the framework of the pharmaceutical industry among the sponsors of clinical trials, ethics committees, clinical researchers and representatives of the Regulatory Authorities.