Monday, 17 April 2023


European Medicines Agency, Amsterdam, the Netherlands

Event summary

EMA is organising 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 will bring 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 are 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.


Workshop - DAY I

Workshop - DAY II


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