Eighth European Medicines Agency (EMA) and EFPIA bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 8 July 2025, 15:00 (CEST) to 8 July 2025, 17:00 (CEST)

Submitted by Anonymous (not verified) on 12 June 2025 - 13:30

Eighth European Medicines Agency (EMA) and EFPIA bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 8 July 2025, 15:00 (CEST) to 8 July 2025, 17:00 (CEST)

Opinion/decision on a Paediatric investigation plan (PIP): Jyseleca, filgotinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Musculoskeletal and connective tissue disorders, PIP number: P/0119/2024

Submitted by Anonymous (not verified) on 12 June 2025 - 13:06

Opinion/decision on a Paediatric investigation plan (PIP): Jyseleca, filgotinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Musculoskeletal and connective tissue disorders, PIP number: P/0119/2024

Human medicines European public assessment report (EPAR): Nyxoid, naloxone, Date of authorisation: 09/11/2017, Revision: 10, Status: Authorised

Submitted by Anonymous (not verified) on 12 June 2025 - 11:07

Human medicines European public assessment report (EPAR): Nyxoid, naloxone, Date of authorisation: 09/11/2017, Revision: 10, Status: Authorised

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 1 December 2025 to 5 December 2025

Submitted by Anonymous (not verified) on 12 June 2025 - 10:19

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 1 December 2025 to 5 December 2025

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 10 November 2025 to 14 November 2025

Submitted by Anonymous (not verified) on 12 June 2025 - 10:18

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 10 November 2025 to 14 November 2025

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 13 October 2025 to 17 October 2025

Submitted by Anonymous (not verified) on 12 June 2025 - 10:17

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 13 October 2025 to 17 October 2025

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 22 September 2025 to 26 September 2025

Submitted by Anonymous (not verified) on 12 June 2025 - 10:16

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 22 September 2025 to 26 September 2025

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