Generic Medicine: IP/Legal and Regulatory Issues

It is often difficult for those involved in marketing generic medicines who work outside Europe to understand the complicated legal and regulatory environment in which EU generic companies operate. Similarly, regulatory people themselves are often unsure how the legal and Intellectual Property framework can influence their own work. The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business. Misunderstanding the various factors that influence the time and speed of registration can lead to regulatory delays with a knock-on effect on launch dates for new products. This can, in turn, lead to undesirable commercial delays, which might have an impact on a company¡¦s competitive position.