Recorded Webinar - Drug Product Submission (NDS) Preparation in CTD and eCTD Format Workshop

Program Details

Time

2 Hours

Cost

CAD$600+HST

Location

Online

Workshop Overview

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.

Who Should Attend

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.

Workshop Outline

This workshop covers the following topics:

Health Canada (HC) Module 1
M1-6 Regional Clinical Information & M1-0-7 General Note to Reviewer
ICH Module 2: Summaries
ICH Module 3: Quality
ICH Module 4: Nonclinical Study Reports
ICH Module 5: Clinical Study Reports
Common Electronic Submissions Gateway (CESG)
Media and Email Submission Processes
Regulatory Transaction Verification
Final Considerations & Best Practices Learning Outcomes

Learning Outcomes

Master Health Canada and ICH Submission Modules

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 Transactions

Learn 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 Processes

Develop the skills to verify regulatory transactions, ensuring compliance with Health Canada’s validation and submission standards.

Implement Best Practices for Successful Submissions

Explore 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.