European Medicines Agency

How to Translate ePI in FHIR XML Format Under the EU Common Standard

Haralabos Papatheodorou2026-09-07T14:51:12+02:00

The European Medicines Agency (EMA) is transitioning from static PDF [...]

How to Translate ePI in FHIR XML Format Under the EU Common StandardHaralabos Papatheodorou2026-09-07T14:51:12+02:00

Haralabos Papatheodorou2026-05-21T14:10:20+02:00

Scope of MDR Technical Documentation Guidance The Team-NB [...]

Medical Devices & Translation Requirements for the Greek Market: Lessons from Team-NB v4Haralabos Papatheodorou2026-05-21T14:10:20+02:00

Haralabos Papatheodorou2026-05-04T17:03:25+02:00

The EMA recently released version 7 of the QRD [...]

EMA QRD Appendix II Update: New MedDRA Standards for Section 4.8 (March 2026)Haralabos Papatheodorou2026-05-04T17:03:25+02:00