AFSA-EFPIA Workshop 2021
The workshop aimed to assess the lingering barriers, to reach a shared agreement on further concrete actions to make the deletion of the test a global concrete achievement. International organisations and funding bodies, industry and its associations, and regulatory stakeholders are invited to share their view and discuss the respective experiences in a multi-stakeholder environment.
Continuing the discussion on the deletion of the ATT remains a key priority for many stakeholders. Despite multiple successful examples of deletions and exemptions (e.g. Europe, USA, Canada, Brazil, Argentina, and partially India and Japan), and WHO’s clear recommendations, a meaningful number of regulatory authorities have yet to evolve in their perspective regarding this test. Cooperation, information exchange and dialogue are still needed to assist regulators in evaluating and embracing change.
Objectives
Building from the results of HSI Symposium (Rome, 2019) and on the IABS Congress (Bangkok, 2019), bring together a wider but specific range of key international and local stakeholders— including new ones with a keen interest in vaccine innovation and increased accessibility through diminished reliance on in vivo testing—to strategically agree on the way forward to the elimination of the ATT from the regulatory requirements for vaccines and biologicals.
Review and update barriers and difficulties hindering the elimination of the ATT in some key regions/countries that are still undecided on the evaluation or implementation of this opportunity.
Identifying concrete action to speed up the decision towards the elimination of the ATT.
Workshop Documents
Keynote Presentations:
- The Global Challenge of Post Approval Changes (PACs)
- The European Directorate for the Quality of Medicines & Healthcare (EDQM)
Read the Workshop report in Biologicals: Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report, Biologicals, 2022.
