Fourth listen-and-learn focus group meeting of the Quality Innovation Group, Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 November 2024 to 20 November 2024
The focus of the Quality Innovation Group's (QIG) fourth listen-and-learn focus group meeting with representatives from academia and industry is on:
- Platforms for medicinal products manufactured using prior knowledge, such as common manufacturing platform approaches (multiple MAs).
- Platforms for medicinal products against agents which are or have a potential to cause serious cross-border threats to health e.g. pandemic/pandemic preparedness (one MA).
- Platforms for the manufacture of personalised or individualised medicines (‘one patient/group of patients-one product’, one MA) e.g. covering different ultra-rare orphan indications.
The aim of the meeting is to discuss key points identified, outlining examples of platform technologies compliant with any of the three categories above and focusing on the scientific challenges and data required to corroborate the proposed ‘platform,’ in line with the considerations included in the linked call for case studies document.
The call for case studies is open until 31 July 2024. Selected case studies will be presented and discussed at the meeting. The meeting is invitation based only to discuss these case studies. A meeting report will subsequently be published.
