Regulation of faecal microbiota transplants (FMT) and FMT-derived medicinal products in the EU

Topics covered in this webinar will include the following: Update on the current status and challenges related to the development and supply of FMT and of FMT-derived medicines across regulatory frameworks and EU Member States; Sharing current experience with the regulation of FMT and FMT-derived medicines , with a view to harmonising approaches across EU Member States and ensuring certainty on evidence-generation requirements to developers, Presentation of the mechanisms for alignment as foreseen in the new Regulation on Substances of Human Origin (SoHO) and the proposed revision of the pharmaceutical legislation.

Target audience: This webinar is targeted at regulators from the EU regulatory network (pharmaceutical framework, i.e. regulators responsible for the regulation of medicinal products, in particular biological quality assessors, non-clinical assessors and members of the BWP, SAWP, NcWP and CHMP.), regulators from the SoHO framework (i.e. NCAs responsible for the regulation of tissues and cells), regulators from the European Directorate for the Quality of Medicines and Healthcare (EDQM), and colleagues from the SoHO and the pharmaceutical teams of DG Sante, European Commission.

Please register for this event through the following Webex registration link: Webex link

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