Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Generic In-licensing - Points to Consider, Regulatory Aspects and Interdependencies ***
Dr. Thorsten Externbrink (Abschlußjahr: 2011)
A license is an opportunity for a generic company to quickly extend the portfolio, to use it as risk mitigation for own developments or for some generic companies as business model to apply for tenders in several EU countries with license products.
Good planning, starting from proper selection of products by portfolio management, choice of the right contract partner, critical assessment of the dossier, launch planning and finally maintenance of the license product are required.
Within the generic company there are many points to consider starting from business perspective, legal and patent views, marketing interests, country organization and regulatory. Each and every license has its own special characteristics and challenges. The registration strategy options are manifold and the work flow between the departments must be clearly defined within the company.
With view to the in-license process the regulatory part starts at time of the dossier review or even before, in preparation of the in-license product using different sources of information. The registration strategy is typically already fixed and given by the development approach. In other cases the registration process is already started and the strategy is not arguable any more. Therefore, for most licenses there is no real discussion about the registration strategy.
The most critical aspect for regulatory is the alignment of work-sharing with the other company.
Work-sharing is usually fixed in the license and supply agreements between the partners, defining who is responsible for what, i.e. submission of initial application or submission of responses during the procedure, contact to Authority, transfer of marketing authorization and the national phase.
This thesis focuses on a specific constellation of interdependencies. However, it reflects most parameters and departments involved in this process and the conjunction with specially focus on regulatory.
Pages: 46