CMC Writing and Submission Strategies

Shrinivas (Cheenu) Murti, Ph.D.

Course description

The CTD is the basis of drug, biologic, and drug-device combination registration applications. A proper understanding of CTD writing strategy and health authority expectations can greatly aid a company in gaining approval. With the prerequisite complete, this accredited training, will provide in-depth instruction on Chemistry, Manufacturing, and Controls (CMC) requirements and review processes for clinical trial, registration, and post-approval drug applications in the US, Europe, and Japan.

Additional considerations and integrative approaches for other key country submissions (Canada, Australia, China, Brazil, Korea, etc.) and Most of the World markets will be presented. Development, manufacturing, analytical testing, controls, and stability issues will be discussed for solids, parenteral and other dosage forms. Overviews of Quality by Design (QbD) submissions and Drug Master Files will be presented. Successful regulatory filing strategies and best practices will be illustrated with examples and case studies.

This course INCLUDES a required prerequisite online course that provides an overview of the regulations, guidelines, and procedures of major health authorities. By understanding the ICH Common Technical Document (CTD) and supporting documents, participants will be ready to move into the intensive, training with a clearer understanding of agency requirements.

Upon completion of this course, you will be able to:

• Describe the regulatory review processes and health authority expectations through the product lifecycle
• Analyze and compile CMC data to support CTD clinical trial applications, registration files, and post-approval submissions in the US and Europe
• Explain special writing strategies for Quality by Design marketing applications, Drug Master Files, and “Most of the World” registration dossiers
• Identify regulatory compliance issues in agency inspections