Effective sharing of drug safety data will require a widely adopted policy framework that addresses non-technical barriers such as organisation, trust and intellectual property. Adoption of drug safety models as part of the submission process requires consultation and collaboration with regulatory bodies to develop accepted standards and documentation.
eTRANSAFE is a large project with participation from industry, SMEs, academia and research infrastructures. Effective project execution requires that procedural, Intellectual Property Rights (IPR) and legal bottlenecks are effectively addressed by capturing the requirements arising from data collection, integration and utilisation, and disseminating and incorporating the required policies and guidelines into working practice.
- Develop the data sharing guidelines and policies necessary for industry and other organisations to share drug safety related data with the aim to improve the feasibility and reliability of translational safety assessment during the drug development process.
- Develop guidelines for predictive model development that describe how models have to be created and documented in order to facilitate their industrial acceptance and approval by regulatory bodies.
- Engage in a continuous dialogue with regulators (EMA – e.g. through the Safety Working Party-, FDA, PDMA, and national regulators) so that the resulting guidelines fit their needs and expectations.