The presentation of BGPharma from the Forum, held on 28th of November 2008 "Current regulatory challenges for Medicinal Products", organized by the Faculty of Public Health and Faculty of Pharmacy, Bulgarian Drug Agency and FORUM Institut fur Management GmbH, Heidelberg, Germany, will be published in magazine "Health Management”.
The aim of the seminar was to present the current challenges in regulatory approaches, respectively pharmaceutical legislation, launched in Bulgaria since the beginning of 2007 and was updated in August 2008. The seminar brought together leading experts from the European Drug Agency EMEA, as well as experts from the Bulgarian Drug Agency and the Medical University of Sofia.
BGPharmA was presented as a new organization that aims to unite and consolidate the interests of all producers of generic medicines in Bulgaria, with the primary mission to promote the introduction of a coherent generic drug policy in the country. The main aims of BGPharmA are:
- consolidation of the generic industry in its efforts to develop and provide medicines at competitive prices for all patients and for the development, adoption and implementation of coherent generic drug policy by the authorities and the health institutions. The regulatory changes in Bulgaria were presented in terms of the generic pharmaceutical industry.
Among the speakers of the Forum were the Director of the German regulatory authorities (BFArM and PEI) Prof. Dr. Johannes Lyover and the Executive Director of Bulgarian Drug Agency, Dr. Emil Hristov. Prof. Dr. Daniel Brasyor, President of Pediatric Committee (PDCO) of EMEA, presented the experience acquired for the European Regulation on Clinical Trials with children. Ms. Truus Yanze-de Hoog, who is Chairman of the Committee for Medicinal Products for Human Use of EMEA, provided the experience for the last two years with the procedures of mutual recognition and the decentralized procedure. The Director of the European Directorate for the Quality of medicines and healthcare (EDQM), Dr. Susanne Kaytel from France presented the changes in EU Regulations.

The presentation of BGPharmA you can see here.

BGPharmA