Greetings!
Knowing the CTD structure is one thing. Managing a complex submission is another.
As an NDS moves through preparation and review, regulatory professionals need to connect quality, nonclinical and clinical documentation, manage the eCTD lifecycle, and respond effectively when Health Canada raises questions or deficiencies.
NDS Level 2: Practical CTD and eCTD Preparation for Drug Product Submissions takes participants beyond the fundamentals and into the practical challenges involved in preparing and managing advanced drug submissions.
Through detailed instruction and real-world case studies, participants will learn how to:
- Prepare advanced content across CTD Modules 3, 4 and 5
- Manage quality, nonclinical and clinical documentation
- Navigate pre-submission meetings with Health Canada
- Respond to NODs, NONs and regulatory queries
- Manage eCTD amendments and submission lifecycles
- Apply effective cross-referencing, hyperlinking and filing practices
- Recognize common challenges through real-world NDS case studies
Ideal for Regulatory Affairs, Quality, Clinical Research and pharmaceutical professionals who already understand the fundamentals and are ready to develop more advanced, practical submission skills.
Move beyond understanding the submission. Learn how to manage it.
*All participants will receive a Certificate of Attendance upon completion. |
