Nov 19 2026, 12:00pm – 1:00pm
Virtual

Following the release and implementation of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R3) Good Clinical Practice (GCP) guidelines, Health Canada updated its guidance document (GUI-0100) to reflect the new requirements and provide greater clarity on their practical application.

In this session, Kevin Donato and Nilufer Hasanova from Health Canada’s Clinical Trials Compliance Program will review key updates to the guidance document, discuss practical compliance considerations, explain how GUI-0100 complements Part C, Division 5 of the Food and Drug Regulations and respond to questions.

In addition, Aleksandra Kuzmanovic, VCHRI quality lead, together with Zoe Glase and Jacquie Stevenson from the Vancouver Prostate Centre (VPC) will provide an overview of VCHRI-specific quality and compliance requirements and resources available to support researchers, including Standard Operating Procedures (SOPs), risk management tools and quality management processes. They will also share key learnings from a recent Health Canada site visit at VPC and highlight how quality management resources can support compliance and continuous improvement in clinical trials.

Learning objectives 

In this session, you will learn how to:

  • Navigate the key changes introduced in ICH E6(R3) and Health Canada's updated GUI-0100 guidance.
  • Apply the principles outlined in GUI-0100 to support compliance with regulatory requirements and GCP.
  • Recognize VCHRI-specific quality and compliance expectations.
  • Identify opportunities to strengthen compliance and inspection preparedness.
About the speakers
Kevin Donato is a senior compliance and enforcement advisor with Health Canada's Clinical Trial Compliance Program (CTCP). He completed his PhD in the Department of Laboratory Medicine and Pathobiology at the University of Toronto and has been with the Regulatory Operations and Enforcement Branch since 2018. Drawing on extensive experience in quality regulations, he works closely with inspectors and the review bureau partners to navigate compliance and enforcement processes as well as risk management, in the evolving clinical trials field.
Zoe Glase is a clinical research assistant at VPC. In her current role, she supports clinical research conducted at the centre with a sponsor lens in mind, with a particular focus on investigator-initiated trials. She believes that communication, collaboration, transparency and curiosity are essential to the successful conduct of research.
Nilufer Hasanova is a senior compliance and enforcement advisor in Health Canada’s CTCP. She joined Health Canada in 2021 while completing her Master of Public Policy, specializing in health and social policy. Since then, she has worked across various compliance and enforcement programs, including Border, Health Products, Cannabis and Clinical Trials. As Registered Nurse, Hasanova has experience in public health, physical rehabilitation, harm reduction, but most notably in research and clinical trials. 
Aleksandra Kuzmanovic is a quality lead at VCHRI. A Certified Clinical Research Professional, she brings more than 20 years of experience in clinical research. In her current role, she supports clinical research across Vancouver Coastal Health through consultation, mentoring, training and guidance on navigating the regulatory environment. Kuzmanovic is a member of the Society of Clinical Research Associates, the N2 Quality Committee and the Association of Clinical Research Professionals. 
Jacquie Stevenson is a regulatory affairs coordinator at VPC. With more than 23 years of experience in clinical research, she has spent the past nine years supporting VPC investigators and the clinical trials unit. In her role, she provides comprehensive administrative support for all aspects of study start-up and regulatory oversight, ensuring compliance with ICH-GCP guidelines and Health Canada requirements. 

This workshop is part of our VCHRI Research Training Series. This series is designed to support the acquisition of advanced skills, techniques and knowledge and lead to enhanced practices in the conduct of research.

Please note that all VCHRI Research Training session are recorded unless otherwise stated.

Primary health service delivery area