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What is BUFER

Clinical research activities include not only scientific and ethical dimension but also regulation at national and international level to assure the protection of participants in clinical trials.
The Association for Good Clinical Practice and Clinical Research Development in Bulgaria organized a Seminar on the Implementation of the EU Directive on Good Clinical Practice in Bulgaria on 10-11 May 2004. Shortly after this Seminar and driven by the necessity for better understanding and faster adoption of the international regulations came the idea to establish one more forum within the framework of the Association Bulgarian Forum of Experts in Regulatory Affairs (BUFER). It will include experts from the Bulgarian Drug Agency, Bulgarian Ministry of Health and the Regulatory Affairs Departments of pharmaceutical companies and CROs.

Objectives of BUFER

1. To keep up-to-date with EU regulatory policies and procedures
2. To create and maintain an effective forum for the exchange of information between pharmaceutical companies and CROs at one hand and the responsible Regulatory authorities on the other
3. To promote the national implementation of progressive regulatory programs and standards in order to achieve highest possible standard of clinical research in Bulgaria
4. To approximate the conditions and the regulatory environment for conducting clinical trials in Bulgaria to the world standards
5. To assure the protection of the rights of study subjects

 

2002 AGCPCRD