Building upon the advanced concepts covered in Level II, this workshop delves deeper into the complexities of preparing New Drug Submissions (NDS) in CTD and eCTD formats for Health Canada. Participants will explore the latest regulatory expectations, advanced lifecycle management strategies, and compliance requirements for post-market submissions. The session will provide detailed guidance on Module 1 (Administrative and Product Information), advanced dossier structuring techniques, and best practices for handling regulatory requests, including responses to Health Canada inquiries and reconsideration requests. By the end of the workshop, attendees will have a high-level understanding of the intricacies of regulatory filings and strategies to ensure successful submissions.
This workshop is designed for experienced regulatory affairs professionals, quality assurance specialists, and individuals responsible for compiling and managing complex new drug submissions. It is particularly beneficial for those who have completed Level II or have significant experience in CTD/eCTD dossier preparation and regulatory compliance.
This workshop covers the following topics:
Gain a deep understanding of HC Module 1 and ICH Modules 2–5, including administrative, quality, nonclinical, and clinical study report requirements.
Navigate eCTD Submissions and Regulatory TransactionsLearn to manage eCTD submissions effectively using Common Electronic Submissions Gateway (CESG) and understand the regulatory expectations for media and email submissions.
Ensure Compliance with Regulatory Verification ProcessesDevelop the skills to verify regulatory transactions, ensuring compliance with Health Canada’s validation and submission standards.
Implement Best Practices for Successful SubmissionsExplore key final considerations and best practices for regulatory dossier preparation, lifecycle management, and Health Canada submission success.
All participants will receive a certificate of attendance upon completion of the workshop.Note: Registration closes one week prior to the start of workshop.
