Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Data Analysis for the development of a database for country specific requirements ***

Angelika Ommeln (Abschlußjahr: 2007)

Language: English

The demands on Regulatory Affairs to acquire regulatory information fast and comprehensive for the planning and development of regulatory strategies and risk analysis as well as for the efficient processing of regulatory activities worldwide are growing constantly. Therefore easy access to information on the country specific requirements is needed especially for RoW countries whos guidelines are very basic or who either do not publish regulatory guidelines at all or do not publish them in English. The implicit, individual knowledge on these countries already existing in the company has to be transformed into explicit knowledge. The systematic storage of the information and know-how in a database can be the solution. The design of a database should be supported by a data model focusing on the representation of the data and information as the users in Regulatory Affairs see it. The data model includes the objects which will be stored in the database as well as the relationships among them. The requirement analysis is used to identify both.

Due to the high number of RoW countries and the abundance of different requirements Middle East countries were chosen for the analysis as deputy for the sometime extensive and sometimes particular requirements. Oman was chosen to illustrate the particular requirements of a new application. The UAE were chosen to describe various issues of a variation application and the renewal requirements of the Iraq were used as starting point for the discussion on re-registrations. For specific requirements not applicable to the three chosen Middle East countries are references were made to countries from other areas. In the analysis the paper discussed important issues and requirements affecting the RoW countries such as company registration including GMP and site master files, the authentication of documents, the country of origin, specific documents such as the CPP and the package insert, stability requirements and dossier requirements.

Further, the future stakeholders of the regulatory information from the country specific requirement database were established with their information needs to clarify the required database output. Based on the described regulatory activities and the anticipated database output the entities could be identified. The relationships between the entities were described, illustrated with examples and visualised in separate graphics. As a final step the separate graphics were combined to complete conceptual data model which can serve as “blueprint” for the further development of the database structure and the physical implementation.

Pages: 34 ; Annexes 6, pages: 45