Orphan and Pediatric Medicinal Products

Orphan and Pediatric Medicinal Products

Join us for our third CLE webinar on the Fundamentals of EU pharmaceutical law, which will focus on the EU Orphan and Pediatric Regulation. 

Topics include:

• orphan drug designation (ODD), in particular, the requirements for its granting and maintenance;
• links between the ODD and the marketing authorization;
• the scope of application of the pediatric requirement, the content of the pediatric investigation plan (PIP), the waivers and deferrals, the compliance check, and the discontinuation of the PIP;
• ancillary pediatric obligations, such as the publication of pediatric study results or the mandatory marketing of the pediatric product; and
• the impact of the revision of the EU general pharmaceutical legislation on the orphan and pediatric regimes.

Regulatory exclusivities will be covered in the next webinar.

For questions, contact Christine Lieber.