Module 5 Presentations

18/07/2024

USA Ethics Committees

 IRB type is dependent on whether the investigator is obligated to use their institution’s IRB.  GP/Practitioner network – central IRB (commercial IRB)  Hospital/CRO clinic – local IRB ● Multisite studies – multiple IRB approvals

 Functions similar to EU EC (Ethics Committee)

The Organisation for Professionals in Regulatory Affairs

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Canadian Clinical Trials

Health Canada ● Pharmaceutical Drugs Directorate ● Biologic and Radiopharmaceutical Drugs Directorate ● Medical Devices Directorate ● Veterinary Drugs Directorate ● Natural and Non-prescription Health Products Directorate

 Pre-CTA consultation meetings can be requested in Canada. Such consultations may be particularly useful for new active substances or applications that will include complex issues that may be new to Health Canada.  CTA must be filed for Phases 1-3 & comparative bioavailability trials – CTAs are not required for Phase 4 studies, if the intended use of the marketed product aligns with the approved indication.  Documentation should support the objectives and goals of the proposed trial, including drug quality data (taken from the IMPD). ● IMPD can be submitted as a pdf Can submit a CTA in eCTD format or non-eCTD format. However, once a CTA/CTA-A has been submitted in eCTD format you cannot switch to non-eCTD format for subsequent submissions. No fees are charged by Health Canada for CTAs.

The Organisation for Professionals in Regulatory Affairs

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