Regulatory Affairs - Completion of Health Canada form PSEAT for CTA application. Peivand Pirouzi, Ph.D.

In this video, Professor Peivand Pirouzi provides a detailed guide on how to complete the Health Canada Form PSEAT (Preclinical Safety Evaluation Assessment Tool) as part of the Clinical Trial Application (CTA) process. This form is a critical component in ensuring the safety and regulatory compliance of clinical trials involving new drugs and biologics in Canada.

Key topics covered include:

An overview of the PSEAT form and its role in the CTA application process.
Step-by-step instructions on how to properly complete the form, ensuring all necessary information is included.
Key sections of the PSEAT form and the type of data required for a successful submission.
How to assess preclinical safety data to meet Health Canada's regulatory requirements.
Common challenges when completing the form and strategies for ensuring accurate and comprehensive submissions.

This video is essential for regulatory professionals, clinical trial sponsors, and anyone involved in the submission of Clinical Trial Applications (CTA) to Health Canada. By following the guidance provided, you can ensure that the PSEAT form is filled out correctly, facilitating the timely approval of clinical trials in Canada.