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Overview

This course will provide a full introduction to CMC with regards to regulatory submissions. This CMC course will be a combination of lectures and practical examples. It will be an interactive course with an opportunity for questions and answers.

The course will be of valuable interest to individuals working in CMC regulatory affairs and to those working in start-ups looking to gain knowledge in the CMC area. Furthermore, it will serve as an introductory course for the following 2-day CMC Workshop.

Learning objectives

  • Discuss CMC submissions to support drug development and beyond
  • Identify expectations and requirements for CMC submissions
  • Describe CMC challenges during drug development
  • Compare guidelines in the CMC area
  • Identify GMP requirements in CMC submissions
  • Consolidate CMC knowledge to build a good foundation for the CMC Workshop

Key topics

  • CMC submissions (IMPD, IND, MAA, NDA/BLA, variations and supplements)
  • CMC development plan (product target profile, CMC teams)
  • CMC guidelines (ICH, EU, US)
  • GMP requirements for regulatory submissions

Who should attend

  • Professionals in CMC regulatory affairs
  • CMC project management
  • Individuals in product development, including start-ups
  • Quality Assurance/Control/Compliance

Level: beginner

 

Agenda

07:30-8:00    Registration

08:00-9:00    Session 1: Introduction/Types of Submissions Affected by CMC

  • Global Health Authorities and Regulatory Review
  • Briefing Package
  • Investigational New Drug Application (IND)
  • Investigational Medicinal Product Dossier (IMPD)
  • Marketing Authorisations (NDA/BLA/MAA)
  • Drug Master Files (DMF)/Active Substance Master Files (ASMF)
  • Amendments to an IND/IMPD
  • Post Approval Changes
  • IND/NDA Annual Reports

09:00-09:45    Session 2:  From Clinical Trial Material to Commercial Product

  • CMC Teams
  • Begin with the End in Mind
  • What is a Target Product Profile?
  • Design Your Ideal Label
  • TOC for a Target Product Profile
  • References (Navigating CMC Guidelines)

09:45-10:15    Coffee Break

10:15-11:15    Session 3: The Global Development Plan

  • Components of a Global Development Plan (GDP)
  • Manufacturing Strategy (CMC Development Plan)
  • Risks and Issues

11:15-12:15    Session 4: Common Technical Document: Module 3

  • Organisation of the CTD
  • Organisation of Module 3

12:15-13:15    Lunch

13:15-13:45    Session 5: Common Technical Document Summaries: Module 2

  • Organisation and Review of Module 2

13:45-14:30    Session 6:  CMC Requirements for an NDA/BLA/MAA

  • Application Summary
  • Drug Substance and Product
  • Deficiencies that Cause Delays

14:30-15:30    Session 7: GMP Requirements/Inspections

  • Good Manufacturing Practice (GMP)
  • General Considerations
  • What is a PAI and Objectives of a PAI?
  • Inspectional Procedures
  • Qualified Person (QP)

15:30-16:00    Coffee Break

16:00-17:00    Session 8: Beyond Approval – Post Approval Changes/Variations

  • Specificities for the US and EU
  • ICH Q12