Dossier Masterclass
UpdatedMaster the global dossier formats used for pharmaceutical regulatory submissions. Explore the eCTD/CTD 5-module structure or the ASEAN Common Technical Document (ACTD) 4-part format with comprehensive guides, templates, and best practices.
Module 1: Administrative Information
Module 1: Administrative Information
Regional administrative documents, forms, and procedural information required for submission.
Key Topics Covered
Module 2: CTD Summaries
Module 2: CTD Summaries
Common Technical Document summaries including quality, nonclinical, and clinical overviews.
Key Topics Covered
Module 3: Quality
Module 3: Quality
Drug substance and drug product quality documentation including manufacturing and controls.
Key Topics Covered
Module 4: Nonclinical Study Reports
Module 4: Nonclinical Study Reports
Pharmacology, pharmacokinetics, and toxicology study reports and supporting data.
Key Topics Covered
Module 5: Clinical Study Reports
Module 5: Clinical Study Reports
Clinical study reports, efficacy, safety data, and patient information.
Key Topics Covered
Ready to Begin?
Start with Module 1 to learn about the administrative foundations of regulatory submissions.
Start Module 1