myGMP: Regulatory Compliance

News

12.12.2024

ICH M15-Leitlinienentwurf zur modellgestützten Entwicklung von Arzneimitteln

12.12.2024

Entwurf des Annex 2 der ICH-Leitlinie E6(R3) veröffentlicht

03.12.2024

EDQM: Neue Guideline für sterile Substanzen veröffentlicht

03.12.2024

eSubmission: Aktualisierungen der "Validation Criteria"

25.11.2024

EDQM: Nachtrag 11.7 zum Europäischen Arzneibuch vorhanden

Guidelines

Important Guidelines on Marketing Authorisation Procedure

Aktuelle Seminare zu Regulatory Compliance

How to register APIs in Brazil - Live Online Training<br>

Thursday, 13 February 2025 10.30 - 15.45 h

How to register APIs in Brazil - Live Online Training
Focus on CADIFA and obtaining a Brazilian GMP certificate

API Regulatory Starting Materials

Munich, Germany
18/19 February 2025

API Regulatory Starting Materials Definition, Manufacture, Assessment and handling post-approval Changes

GMP meets Regulatory Affairs

Barcelona, Spain
19/20 March 2025

GMP meets Regulatory Affairs Applying for and maintaining marketing authorisations: What you need to know from a GMP perspective

mehr Seminare zu Regulatory Compliance