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This is the sixteenth in a series of regular meetings between regulators and representatives of industry stakeholder organisations. It addresses all areas of evidence generation along the medicine's life cycle and related to development support activities, such as scientific advice and qualification, as well as specifics for paediatric and orphan medicines. This meeting focuses on:
- strengthening the delivery of scientific advice to efficiently support development programmes, including latest progress on agile scientific advice, the pilot on scientific advice specific for model-informed drug development and scientific advice for combination developments;
- survey on experience and expectations with parallel EMA/FDA development support;
- continuous evolution of the PRIME scheme;
- modernising the qualification of novel methodologies framework;
- role and activities of the R&D stakeholder platform in the implementation of the New Pharmaceutical Legislation;
- progressing the support to paediatric developments;
- initial considerations on the new concept of a 'regulatory sandbox';
- focus group to explore opportunities for the use of real-world data and the generation of real-world evidence;
- development of a new guidance for reporting on indirect comparisons;
- proposal for the pilot of a voluntary data submission framework to establish potential alternatives to animal testing in line with the 3Rs principles;
- follow-up discussion on the identification of product-specific bioequivalence guidelines.
Registration by invitation only