NVFG RegNed Verdiepingscursus

Course Orphan Medicinal Products

8 November 2022

Want to know more about the clinical and regulatory framework of Orphan Medicinal Products? Sign up for the in depth RegNed course on this topic to learn all about the investigators’, applicants’ and regulators’ perspective. In this interactive course the opportunities, challenges, regulations and regulatory procedures for bringing Orphan Medicinal Products to the market will be addressed.

This course is organised by RegNed, a division of NVFG.

Course content

The aim of the course is to introduce participants to Orphan Medicinal Products and the way these products are investigated, assessed and approved in the EU. The unique features of Orphan Medicinal Products versus “regular” medicinal product will be taken into account.

The following topics will be addressed during this one day training:

• Understanding of orphan indications, regulatory definitions and incentives
• Orphan drug designation (ODD) with focus on the EU regulations and procedures
• Challenges for development and clinical studies in rare diseases
• Marketing authorization application requirements
• Conflicting interests: business, patient, regulatory, reimbursement
• Use of registries and Real World Evidence
• EMA and Dutch registry initiatives
• Case studies

Participants profile

We welcome RA professionals who are interested in Orphan Medicinal Products and who would like to broaden their knowledge. General basic RA knowledge rather than experience in rare diseases /Orphans is expected.

Practical information

• Date: 8 November (Tuesday), 9:00h to 17:00h
• Location: Postillion Hotel, Bunnik
• Fee: € 300,- (excl. VAT) for NVFG members, € 450,- (excl. VAT) for non-members
• Maximum of 30 participants: register now!

For a more detailed description, please click here