Human medicines European public assessment report (EPAR): Lyxumia, lixisenatide, Date of authorisation: 31/01/2013, Revision: 21, 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
Human medicines European public assessment report (EPAR): Infanrix Hexa, diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed), Date of authorisation: 23/10/2000, Revision: 48, Status: Authorised
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
Human medicines European public assessment report (EPAR): Dovprela (previously Pretomanid FGK), pretomanid, Date of authorisation: 31/07/2020, Revision: 11, Status: Authorised