EU Regulatory Affairs strategy during development of medicinal products

Overview
The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider.

The regulatory plan describes the regulatory strategy, as well as pricing and reimbursement issues in your development.
Orphan Medicinal Products will be discussed, and the advantages of having a status as an orphan medicinal product will be explained. Incentives for the development of orphan medicinal products have been available in the United States of America since 1983 and in Japan since 1993, and also the EU offers a range of incentives to encourage the development of these medicines.

To benefit from the incentives, sponsors intending to develop an orphan medicine must submit an application to the EMA requesting 'orphan designation' for their medicine.