This introductory workshop provides a high-level overview of the New Drug Submission (NDS) process, focusing on the essential components required for preparing regulatory submissions. Participants will gain foundational knowledge of the Common Technical Document (CTD) structure and the electronic Common Technical Document (eCTD) format, the key documentation requirements, and the regulatory expectations from Health Canada. The session will also cover the basics of the drug development process, the NDS filing process, and the importance of pre-submission meetings. By the end of the workshop, participants will understand the general steps involved in preparing and submitting an NDS, encouraging further participation in more detailed workshops.
This workshop is designed for individuals new to Regulatory Affairs or those interested in understanding the basics of the New Drug Submission process. It is particularly beneficial for professionals working in the pharmaceutical and healthcare industries, including regulatory affairs specialists, drug development professionals, quality assurance personnel, and anyone involved in drug submissions and approvals.
This workshop covers the following topics:
Gain a clear understanding of the regulatory framework and the essential components involved in preparing a New Drug Submission.
Comprehend the CTD StructureLearn the structure and purpose of the Common Technical Document (CTD) and the advantages of the eCTD format in regulatory submissions.
Familiarize with Key Regulatory ExpectationsUnderstand the documentation requirements and Health Canada’s expectations during the NDS submission process.
Recognize the Importance of Pre-Submission Meetings:Learn how pre-submission meetings can facilitate a smoother submission process and align expectations with Health Canada.
All participants will receive a certificate of attendance upon completion of the workshop.Note: Registration closes one week prior to the start of workshop.
