Presentation title: Overview of the draft revised Health Canada Guidance for Clinical Trial Sponsors - Clinical Trial Applications

Speaker: Celia Lourenco, PhD, Manager, Clinical Trials Group I (Toronto)

Abstract: The Health Canada Guidance for Clinical Trial Sponsors - Clinical Trial Applications released in 2003 has undergone revisions, some of which include consolidation of 2 guidance documents, addition of guidance related to the requirements for clinical and quality CTA-Amendments versus CTA-Notifications, addition of filing requirements for the importation of clinical trial drugs, and changes to the policy on the 7 day administrative target. The current draft of the revised Guidance Document was released on November 7, 2011, for a 90 day stakeholder consultation period, which will end on February 4, 2012. This presentation will provide an overview of the draft guidance, including highlights of the changes, and will be an opportunity for discussion and stakeholder feedback.

Presentation title: Overview of the draft revised Health Canada Guidance for Clinical Trial Sponsors - Clinical Trial Applications

Speaker: Dr. Léo Bouthillier, Ph.D., Manager, Clinical Trials Group II (Montreal)

Abstract: The Health Canada Guidance for Clinical Trial Sponsors - Clinical Trial Applications released in 2003 has undergone revisions, some of which include consolidation of 2 guidance documents, addition of guidance related to the requirements for clinical and quality CTA-Amendments versus CTA-Notifications, addition of filing requirements for the importation of clinical trial drugs, and changes to the policy on the 7 day administrative target. The current draft of the revised Guidance Document was released on November 7, 2011, for a 90 day stakeholder consultation period, which will end on February 4, 2012. This presentation will provide an overview of the draft guidance, including highlights of the changes, and will be an opportunity for discussion and stakeholder feedback.