Regulatory Affairs - Health Canada-Preparation of Meeting Application Packages for CTA,NDS,SNDS. Peivand Pirouzi, Ph.D.

In this video, Professor Peivand Pirouzi provides a comprehensive guide on how to prepare Meeting Application Packages for key regulatory submissions to Health Canada: Clinical Trial Applications (CTA), New Drug Submissions (NDS), and Supplemental New Drug Submissions (SNDS). These application packages are critical for initiating and advancing the regulatory review process for pharmaceutical products in Canada.

Key topics covered include:

An overview of the regulatory submission process for CTA, NDS, and SNDS in Canada.
Step-by-step guidance on preparing the necessary documentation and information for each type of submission.
How to structure your Meeting Application Package to ensure compliance with Health Canada's requirements.
Key considerations for including clinical trial data, manufacturing details, and other critical information.
Best practices for submitting and managing these application packages to streamline the regulatory process.
Insights into common challenges faced by pharmaceutical companies and how to mitigate them when preparing your application.

This video is an essential resource for pharmaceutical professionals, regulatory affairs specialists, and anyone involved in the submission process for clinical trials or new drugs in Canada.