EMA multi-stakeholder workshop on qualification of novel methodologies
Event
Human
Date
- Monday, 17 April 2023, All day
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
Event summary
EMA has organised a multi-stakeholder workshop on qualification of novel methodologies. Qualification of novel methodologies was introduced in 2008. Ever since, it has provided a platform for iterative prospective discussion and agreement of evidence generation plans for future qualification (Qualification Advice), as well as for agreement and publication of scientific opinions once a novel methodology has been demonstrated to be valid to inform regulatory decision making (Qualification Opinion). The workshop has brought together academia, learned societies, public-private partnerships, consortia, patients, HTA bodies, regulators and industry to explore the scope, process and outcomes of the qualification of novel methodologies platform.
The aims of the workshop were to:
- confirm the future scope of qualification of novel methodologies in the light of ever accelerating development of science and technologies, to best support translation of innovation into patient benefit;
- look at use case examples of different methodologies, share procedural experiences and solicit input from stakeholders to identify recommendations to future proof the qualification of novel methodologies process and its outcomes.
Following the workshop recommendations, an action plan for the future-proofing of the qualification of novel methodologies has been agreed.
Recordings
Workshop - DAY I
Workshop - DAY II