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Hilton Lac-Leamy

2024年11月05日 (火) 午前 8:30 - 2024年11月05日 (火) 午後 12:00

3 Boulevard du Casino, Gatineau, QC J8Y 6X4, Canada

Short Course: Best Practices for Clinical Trial Applications in Canada

This is a Virtual Pre-Conference Short Course in conjunction with the Canada Annual Meeting.

概要

Navigating the regulatory requirements of Clinical Trial Applications (CTAs) in Canada can be challenging to sponsors. Submission of high-quality CTAs is essential for an efficient drug development process and benefits both Health Canada and the industry.

This short course offers a comprehensive exploration of the different aspects of Clinical Trial Applications (CTAs) in Canada including clinical, quality, and publishing and provides a unique opportunity to hear the perspective of both Health Canada and the industry.

Through a combination of Health Canada and Industry speakers, the course will inform professionals in the pharmaceutical, and biotechnology industries, as well as clinical researchers and regulatory affairs specialists, on the requirements and best practices for CTA in Canada.

By the end of the course, the participants will have learned how to address challenges, avoid pitfalls and adopt strategies to ensure the preparation and submission of a high-quality CTA.

 

Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording! Note: You do not need to register for the full Canada Annual Meeting to attend this Virtual Short Course.

学習目的

At the conclusion of this course, participants should be able to:
  • Explain Health Canada structure and management of CTAs
  • Define what are some of the issues and findings related to CTA submissions and determine when a pre-CTA meeting would be beneficial
  • Describe the best practices and strategies that sponsors can apply throughout the CTA lifecycle
  • Discuss how to prepare and submit CTAs of high quality
  • Recall the best practices and challenges when preparing/publishing electronic CTAs, recognize the similarities and differences between IND and CTA and identify challenges when converting a US IND to a CTA

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