Legal & Regulatory Affairs Committee
EMA recently held two workshops online relevant to EBMT:
- Workshop on the General Data Protection Regulation (GDPR) and secondary use of data for medicines and public health purposes - 19/09/2020
- Workshop on the draft guideline on registry-based studies - 19/10/2020
> was on the draft guideline on registry-based studies: https://www.ema.europa.eu/documents/scientific-guideline/guideline-registry-based-studies_en.pdf
EBMT was invited to give a registry holder perspective on the proposed guideline along with other stakeholders including regulators, pharmaceutical industry and patients.
Both areas are relevant to EBMT in terms of the registry operations and data collection. EBMT actively engages with European regulatory bodies on policy areas affecting our field in a spirit of collaboration and openness.