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This course will give participants the necessary overview of the Health Canada guidance documents for the preparation of a new Drug Submission (NDS) for Chemical drugs, biologicals, biopharmaceuticals, biosimilars and chemical generics. Using the ICH Common Technical Document (CTD) module format outline, significant Chemistry Manufacturing and Controls (CMC), Nonclinical and Clinical areas will be analyzed and discussed and participants will work on a mock submission binder.
Course Outline - Drug Development and NDS preparation
- Guidance Document: Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format
- CTD Structure and Content
- Structure of Drug Regulatory Activities in the Common Technical Document (CTD) Format
- Module 1: Administrative and Product Information
- Module 2: Common Technical Document (CTD) Summaries
- Module 3: Quality
- Module 4: Nonclinical Study Reports
- Module 5: Clinical Study Reports
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