Pre-Clinical Trial Application (CTA) Consultation Meeting

Description

The pre-CTA consultation meeting provides an opportunity for the sponsor to present relevant data, discuss concerns and resolve issues regarding drug development. It also gives Health Canada an opportunity to provide guidance on the acceptability of the proposed trial(s).

Resources

Name Format Description Link
Pre-Clinical Trial Application (CTA) Consultation Meeting HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/pre-clinical-trial-application.html
Pre-Clinical Trial Application (CTA) Consultation Meeting HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/essais-cliniques/reunion-consultation-prealable-depot-demande.html

Tags

Topics

Categories