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In drug development, the step from foundational knowledge to advanced expertise often determines whether a submission advances smoothly through Health Canada or stalls in drawn-out correspondence. Level I built the structure. Level II now takes professionals deeper- into the preparation of New Drug Submissions in CTD and eCTD formats, with all their technical and procedural demands.
This advanced workshop moves beyond concepts into the applied challenges of Modules 3, 4, and 5- where quality data, nonclinical findings, and clinical results must withstand scrutiny. It guides participants through the realities of pre-submission meetings, notices of deficiency and non-compliance, and the disciplined responses that protect timelines and credibility. It demonstrates how mastery of eCTD transforms regulatory interaction into an organized, efficient process rather than an administrative burden.
Participants will not only gain clarity on advanced requirements but will also learn how to anticipate Health Canada’s expectations and avoid common pitfalls. Real-world case studies illustrate what separates successful submissions from costly setbacks. By the end, the process of structuring and defending a new drug submission will no longer appear uncertain- it will stand as a capability you can rely on. | 
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