Haemophilia registries workshop
EventCorporate
Date
- Friday, 08 June 2018
Location
- European Medicines Agency, Amsterdam, the Netherlands
The objective of this workshop is to ensure the practical implementation of the requirements related to patient registries for haemophilia medicinal products in Europe, in line with the draft revision of the Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products. The aim is to agree on the use of registry data for regulatory purposes for haemophilia medicinal products in terms of data access and data sharing/reporting between all involved stakeholders, including patients, physicians, registry holders, marketing authorisation holders/applicants, regulatory authorities and health technology assessment bodies. In addition the additional data elements that could be collected by registries for novel products (such as gene therapy, PEGylated medicinal products and monoclonal antibodies) will be discussed as well as quality of life elements. This call for expressions of interest is open until 13th April.