Advanced CMC Requirements for Generics Applications (ADVANCED CMC FOR GENERICS)

# Advanced CMC Requirements for Generics Applications

Advanced CMC Requirements for Generics Applications is a comprehensive 2-day Live Online Training Course organized by Fleming Events for pharmaceutical, biotechnology, and life sciences professionals who want to strengthen their expertise in **Chemistry, Manufacturing and Controls (CMC)** for generic drug applications.

📅 Date: 4–5 November 2026

🕘 Time: 09:00–17:15 CET (Participant Login: 08:45 CET)

📍 Venue: Live Online Training (Accessible Worldwide)

🌍 Location:** Online Event (CET Time Zone)

👨‍🏫 Course Leader: Dr. Helmut Vigenschow (Germany) – Senior Pharmaceutical Consultant and Founder of ViPharmaService with more than 30 years of experience in Regulatory Affairs, Pharmaceutical Development, Quality Assurance, GMP, Quality Control, Project Management, and CMC Compliance. He has also served as a visiting lecturer and supported global pharmaceutical organizations as an independent consultant.

💶 Registration Fee: From €1,296 (includes access to live online sessions, interactive discussions, course documentation, and Certificate of Completion).

As regulatory expectations continue to evolve across international markets, pharmaceutical companies must prepare high-quality CMC documentation to achieve successful marketing authorization for generic medicines. This advanced training has been specifically developed to help professionals understand the latest regulatory expectations from ICH, EMA, and FDA while minimizing regulatory deficiencies, review cycles, and approval delays.

Throughout the programme, participants will gain practical knowledge on preparing compliant **CTD Module 3** dossiers for both **Active Pharmaceutical Ingredients (APIs)** and finished drug products. The training covers manufacturing process descriptions, API specifications, drug product specifications, stability studies, nitrosamine risk management, pharmaceutical development strategies, formulation development, manufacturing process development, scientific writing, and current pharmaceutical challenges.

The course also provides detailed guidance on **Drug Master Files (DMFs), Active Substance Master Files (ASMFs), Certificates of Suitability (CEPs), process validation, continuous process verification, technology transfer, analytical method transfer, lifecycle management, regulatory variations, ICH Q12 implementation, AI applications in CMC documentation, extractables and leachables, control strategies, and future ICH and EMA guidelines.**

Participants will benefit from **expert-led presentations, real-world case studies, hands-on examples, interactive discussions, networking opportunities, live Q&A sessions, and practical industry insights** that can be immediately applied to pharmaceutical regulatory projects.

Who Should Attend?

• Regulatory Affairs Professionals
• CMC Regulatory Specialists
• CMC Project Managers
• Pharmaceutical Development Scientists
• Manufacturing Professionals
• Quality Assurance (QA) Managers
• Quality Control (QC) Managers
• Process Validation Specialists
• GMP & Quality Compliance Professionals
• CTD/eCTD Authors
• Pharmaceutical R&D Teams

Key Benefits of Attending

• Master advanced CMC requirements for generic medicines.
• Understand the latest ICH, EMA, and FDA regulatory expectations.
• Improve CTD Module 3 preparation and dossier quality.
• Learn best practices for DMFs, ASMFs, CEPs, and regulatory documentation.
• Strengthen knowledge of process validation and technology transfer.
• Reduce regulatory deficiencies and accelerate product approvals.
• Stay updated on lifecycle management, regulatory variations, and emerging global guidelines.
• Receive comprehensive training materials and a Certificate of Completion.

This intensive online training provides an excellent opportunity to learn directly from one of the industry's leading regulatory experts while developing practical skills that support successful generic drug submissions and long-term regulatory compliance.

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