German Society for Regulatory Affairs (DGRA)
Purpose and Aims of the DGRA
Why a German Society for Regulator Affairs?
The German pharmaceutical industry is a global leader in the export of drugs and is therefore a crucial economic factor for Germany as an industrial location.
The pharmaceutical industry is stringently regulated at the national and international level by governmental agencies, laws, directives, guidelines and recommendations which govern the manufacture, approval and marketing of drugs and other medicinal products.
Regulatory Affairs (RA) is the main contact at many pharmaceutical companies for coordinating these matters and therefore plays a key role in the success of a company.
The pharmaceutical industries in the USA, Great Britain and France has long been aware of the critical importance of regulatory affiars. Consequently, associations were long ago set up in these countries whose declared goal is to represent national interests in matters pertaining to the elaboration and implementation of new regulations and, to this end, ensure appropriate training and further training of qualified personnel.
The Society for Drug Regulatory Affairs is the first body in Germany whose purpose is to actively seek to improve and promote exchange between the industry, governmental authorities, ministries and regulatory institutes. As a competent mediator, the DGRA assumes a neutral position in these matters.
The second major function of the DGRA is to improve education in the field of drug regulatory affairs. Until now the only course of studies available was a programme in Cardiff leading to a Diploma of Regulatory affairs. Other further education course such as at the ECPM in Basel and the Witten-Herdecke University are not specifically set up with regulatory affairs in mind or do not lead to an internationally recognized degree.
The nature of regulatory affairs in daily practice has become more and more complex and multifarious in recent years. The obligation to adapt to EU legislature, the dictates of advancing globalization and the opening of new markets have all made it necessary for pharmaceutical companies to be intimately acquainted with national and international regulations governing the licensing of new drugs. This situation demands the targeted training of new employees and the further qualification of those already working in this area.
The Master of Drug Regulatory Affairs study programme is the only advanced degree offered in Germany with tutors drawn from from government bodies, institutes and pharmaceutical companies. The programme aims to explore the complex issues of regulatory affairs from various perspectives and makes them accessible to participants.
In the long term the DGRA's work will help to raise Germany's standing in the field of regulatory affairs and ensure that the national interests of the German pharmaceutical industry are better represented at the international level.
What is the German Society for Regulator Affairs?
The DGRA is a registered non-profit-making society.
The founding members are drawn from universities, government agencies, the pharmaceutical industry and jurisprudence.
The main aims of the society are to:
- Create a platform for interdisciplinary communication between universities, industry and government.
- Promote education and training in the field of regulatory affairs.
What has the German Society for Regulator Affairs so far achieved?
For the first time in Germany, an academic course of studies leading to a Master of Drug Regulatory Affairs was set up in cooperation with the University of Bonn.
What does the German Society for Regulator Affairs have to offer you as a member?
- A forum for everyone involved in the subject of regulatory affairs.
- Training and advanced training for you and your staff
- Up-to-date job ads
- Working groups dedicated to specific regulatory affairs issues
- Reduced attendance fees at events
What advantages do you gain by studying in the Drug Regulatory Affairs programme?
By earning a Master of Drug Regulatory Affairs, you can obtain an internationally recognized academic degree in a future-oriented field with outstanding career prospects.
Within the programme you will establish personal contacts with representatives from government agencies, industry and universities which will form a basis for exchange and cooperation throughout your professional life.
The DGRA needs your cooperation, your specialist knowledge and your personal experience.
Shape your future with the DGRA!