Regulatory Affairs and CMC Conference - Regulatory and quality update and current challenges - 2026

- Update on the new EU Pharmaceutical Legislation - AI/Automation in Regulatory Affairs - New EU Variation Guideline - CMC aspects of New ICH Guideline M13A and Draft Guideline M13B - Update from APIC on Nitrosamines and ICH M4Q(R2) - Revision: Q&As on Post Approval Change Management Protocols (PACMP)The event will cover recent updates and practical implications of the EU pharmaceutical legislation, the application of AI in RA, and the new EU Variation regulation. Additionally, it will address the latest developments in quality (draft) guidelines: ICH M13A + M13B, ICH M4Q(R2), an update on the ongoing discussions on nitrosamine contaminations, and the revision of PACMP, Lifecycle Management.LernzieleAre you working in Regulatory Affairs, CMC, or Quality Assurance? Then dont miss this event.- This conference will address practical questions and provide strategic insights into crucial trends affecting these fields.- Engage in in-depth discussions with our experts and network with your colleagues in the industry.ZielgruppenThis online conference is ideal for anyone working in the pharmaceutical industry and dealing with regulatory or CMC matters. Professionals in the following departments will benefit particularly: - Marketing Authorisation/Regulatory Affairs/CMC - Quality Assurance/Quality Control/Analytics