CMC Submissions in CTD Format

Who Should Attend
This course is intended for individuals responsible for R&D/technical writing/quality management/submissions in pharmaceutical companies, especially those in:

  • Regulatory Affairs
  • Process Chemistry
  • Preformulation and Formulation Development
  • Scale-up and Technology Transfer
  • Analytical Chemistry
  • QA/QC

Experience of one year or more in one of the above areas is recommended to fully benefit from this course.

Description
This course will provide in-depth instruction on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registration and postapproval applications in the US and Europe. Additional considerations and integrative approaches for submissions in Japan and other markets will be discussed. Emphasis will be placed on current FDA, EU and ICH guidelines for the CTD Quality section and will cover development, manufacturing (including sterilization), analytical, controls and stability issues. Successful regulatory filing strategies will be illustrated with examples and case studies. Overviews of Quality By Design (QbD) submissions, Drug Master Files and special requirements for biologics will be presented.