Date: 4–5 November 2026
Time: 09:00–17:15 CET (Both Days)
Venue: Live Online Training Course
Trainer: Dr. Helmut Vigenschow, Germany – Senior Pharmaceutical Consultant and Founder of ViPharmaService with over 30 years of international experience in Regulatory Affairs, Pharmaceutical Development, Quality Assurance, GMP, and CMC compliance.
The Advanced CMC Requirements for Generics Applications training course is an intensive two-day programme developed for pharmaceutical professionals seeking an in-depth understanding of Chemistry, Manufacturing and Controls (CMC) requirements for generic drug applications. As global regulatory expectations continue to evolve, preparing robust CMC documentation is essential for achieving successful marketing authorizations while minimizing review cycles, deficiency letters, and regulatory delays.
The programme provides comprehensive guidance on preparing high-quality CTD Module 3 documentation for Active Pharmaceutical Ingredients (APIs) and finished drug products in accordance with the latest ICH, EMA, and FDA guidelines. Participants will learn how to prepare compliant manufacturing process descriptions, establish appropriate specifications, perform stability studies, manage nitrosamine risks, and understand current pharmaceutical development strategies.