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Human medicines European public assessment report (EPAR): Multaq, dronedarone, Date of authorisation: 25/11/2009, Revision: 20, Status: Authorised
Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine,elasomeran,elasomeran / imelasomeran,elasomeran / davesomeran,andusomeran, Date of authorisation: 06/01/2021, Revision: 48, Status: Authorised
Harnessing AI in medicines regulation: use of large language models (LLMs)
Guiding principles on the use of large language models in regulatory science and for medicines regulatory activities
Factsheet - four principles for safe and responsible use of large language models
Standard operating procedure for renewal of micro-, small- or medium-sized-enterprise status
Standard operating procedure for assignment of micro-, small- or medium-sized-enterprise status
EMA multi-stakeholder workshop on qualification of novel methodologies, Online, European Medicines Agency, Amsterdam, the Netherlands, 17 April 2023
Human medicines European public assessment report (EPAR): Dovprela (previously Pretomanid FGK), pretomanid, Date of authorisation: 31/07/2020, Revision: 11, Status: Authorised