Building on the foundational knowledge of Level I, this advanced workshop focuses on the detailed preparation of New Drug Submissions (NDS) in both CTD and eCTD formats, as required by Health Canada. Participants will explore more in-depth aspects of regulatory submissions, including complex elements of CTD modules, advanced requirements for regulatory filings, and best practices for managing the submission lifecycle. This workshop will cover technical aspects of Modules 3, 4, and 5, including quality, nonclinical study reports, and clinical study reports. Attendees will also learn how to conduct pre-submission meetings, respond to regulatory queries, and utilize the eCTD format to streamline regulatory interactions. By the end of this workshop, participants will have a solid grasp of advanced regulatory requirements and practical skills for effective submissions.
This workshop is designed for regulatory affairs professionals, quality assurance specialists, and individuals involved in preparing and managing new drug submissions in the pharmaceutical industry. It is particularly beneficial for those who have completed Level I of this workshop or have foundational knowledge of CTD and eCTD formats. Professionals working in quality control, clinical research, and regulatory compliance who want to deepen their expertise in advanced drug submissions will also find this training highly valuable.
This workshop covers the following topics:
Develop a comprehensive understanding of advanced requirements for preparing Modules 3, 4, and 5 in CTD format.
Manage Pre-Submission Meetings and Regulatory ResponsesLearn how to conduct effective pre-submission meetings, respond to Health Canada inquiries, and address deficiencies or non-compliance issues.
Utilize eCTD for Regulatory SuccessGain hands-on skills for managing submissions in eCTD format, including document preparation, lifecycle management, and responding to requests for additional information.
Handle Regulatory Queries and Case StudiesAnalyze real-world case studies to learn best practices for maintaining compliance and successfully managing regulatory queries throughout the submission lifecycle.
All participants will receive a certificate of attendance upon completion of the workshop.
