Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Generic Medicinal Product Portfolio from a Regulatory and Business Development point of view ***

Dr. Oliver Weyand (Abschlußjahr: 2005)

Language: English

The portfolio of medicinal products forms the basis for the potential financial achievements of a pharmaceutical company. The addition of the most promising new products as well as an intelligent maintenance of existing products require the right decisions - in commercial as well as technical terms to be made. In fact, technical and commercial issues actually can not be separated from each other.

Each step of the complete life cycle of a medicinal product, starting from the very first idea until the product is not profitable any longer, calls for the involvement of Regulatory Affairs. Therefore, all data relevant to the registration of a product are handled by the Regulatory Affairs team, causing it to represent the interface to almost all other departments of a pharmaceutical company, which in turn provides the privilege of a respective product overview.

Likewise, the initiation of a pharmaceutical development program or in-licensing of a product or sourcing existing products from alternative manufacturers or out- licensing or even withdrawing non-profitable products all represent business decisions, which will have to be put into practice by the Regulatory Affairs team.

Thus, it becomes evident that profound mutual implications exist between Business Development and Regulatory Affairs undertakings. Business strategies have to thoroughly consider the technical and administrative consequences, clearly necessitating the advice of the Regulatory Affairs team. Baring in mind the financial consequences of for instance a delayed approval or a rejected renewal application, regulatory performances obviously evenly affect the work of the Business Development team, which in both cases would have to in-license such medicinal product.

Hence, pharmaceutical business enjoys direct commercial benefit of a competent and effective Regulatory Affairs department.