Regulatory Exclusivities

Join us for our fourth CLE webinar on the fundamentals of EU pharmaceutical law, which will focus on regulatory exclusivities.

Topics include:

• data exclusivity, its limitations, the concept of global marketing authorization and the concept of new active substance;
• market exclusivity, in particular its link to orphan designation; and
• pediatric exclusivities and their substantive and procedural requirements. 

For questions, contact Christine Lieber.