Agenda

Conducting Clinical Trials in Canada: Canadian Regulatory Virtual Conference


*All times in Eastern Time Zone


DAY ONE

1:00 – 2:00     Investigational Products
Jeffrey Doi, HonBSc, BScPharm, RPh, BCPS, Clinical Trials Pharmacist, Princess Margaret Cancer Centre, UHN
Investigational Drug Services (IDS) is a specialized area of pharmacy practice that requires adherence to standard best practices and regulations governing both the pharmacy profession and clinical trial conduct. Mr. Doi will provide an overview of the practical challenges and solutions in applying Division 5 requirements to everyday practice of an IDS pharmacy, covering topics that include drug labeling and preparation for audits/inspections.

2:00 - 3:00     Monitoring Investigator-Initiated Trials
Lisa Johnston, BScN, CCRP, Clinical Research Facilitator, Ottawa Hospital Research Institute
Investigator-sponsored research requires the same regulatory burden as trials sponsored by pharmaceutical or biotech companies. In many cases however, clinical research personnel have overlapping roles on behalf of the sponsor and investigator. Ms. Johnston will focus on the challenges faced with investigator-sponsored studies in meeting Canadian regulatory requirements, and provide strategies for effective study conduct in achieving regulatory compliance.

3:00 - 3:30     Break

3:30 - 4:15     Overview of the Cannabis Research Licence 
Celine Beaupre, Manager of Specialized Licencing and Exemptions, Health Canada
Jérémie Savard, Regulatory Affairs Supervisor, Specialized Licencing and Exemptions Section, Controlled Substances and Cannabis Branch, Health Canada
Mélissa Riverin, Regulatory Affairs Supervisor, Specialized Licencing and Exemptions Section, Controlled Substances and Cannabis Branch, Health Canada
The Cannabis Act and Cannabis Regulations provides the framework for legal access to cannabis and control and regulate its production, distribution and sale. As part of it’s commitment to support and facilitate research and testing with cannabis the Government has created under this framework distinct licences for research and analytical testing. To provide guidance to stakeholders and applicants, This presentation will include an overview of the application requirements and the process involved in becoming a research and/or analytical testing licence holder under the Cannabis Act and Cannabis Regulations.

4:15 - 4:30     Faculty Q&A


DAY TWO

1:00 - 2:00     Conducting Clinical Trials under the Tri-Council Policy Statement
Martin Letendre, LLB, LLM, President, ethica Group of Companies
Through this presentation, participants will be invited to look at the conduct of a Canadian multicenter clinical trial governed by the Tri-Council Policy Statement (TCPS) from both a Sponsor/CRO and a Site perspective. Participants will have the opportunity to identify how the TCPS requirements supplement ICH-GCP guidelines. The presentation will explore the TCPS from study conception, through study initiation, participant recruitment, study monitoring, and publication of study results.

 2:00 – 3:00     Conducting Investigator-Sponsor Trials According to Health Canada’s Guide 100: Everything you need to know
Velma Marzinotto, RN, BScN, CCRP, Independent Consultant
In these challenging times, it is still imperative that the PI/Sponsor conducts clinical drug trials according to all the rules and regulations. Ms. Marzinotto will discuss the roles and responsibilities of the PI/Sponsor as outlined in Health Canada’s Guide 100 to ensure that the entire research team can conduct the trial properly.
3:00 - 3:30     Break

3:30 – 4:15     Clinical Data Management: What You Need to Know
Aisling Wynne BSc. CCDM, Supervisor, Clinical Data Management, Everest Clinical Research
Ms. Wynne will review the data management structure in relation to biometrics. She will also provide an overview of data management processes and associated documentation. She will describe the data management standards from raw data to regulatory submission and the key step in-between.

4:15 - 4:30     Faculty Q&A


DAY THREE

1:00 – 2:15     ICH E6(R2): Good Clinical Practice
Velma Marzinotto, RN, BScN, CCRP, Independent Consultant
This presentation will focus on the Responsibilities of an Investigator as outlined in ICH E6(R2) Guidelines Sections 4.1 to 4.13. Sections reviewed will be: Qualifications, Task Delegation, Time and Resources, REB/IRB Communication, Informed Consent, Investigational Product, Protocol Adherence, Safety Reporting, and Documentation.

2:15 - 2:45     Break

2:45 - 3:30     Process Improvement in Clinical Research
Ali Shahzada, B.Eng, M.Eng, MBBLSS, Executive Director, The Value Collaborative
Mr. Shahzada will discuss that in clinical research, turnaround time and data variation can detrimentally influence projects. Lean/Six Sigma methodologies have long been used in a variety of industries to reduce these same type of issues. In this talk, he will aim to provide an overview of what is lean/six sigma, and how its tools can be used to create a better flow and efficiency for clinical trials.

3:30-4:00     Overcoming Permission to Contact Barriers
Sujata Pokhrel, HBSc, CCRP, Clinical Research Associate, Royal Victoria Regional Health Centre
Permission To Contact (PTC) is a program with a goal to increase and streamline patient access to clinical trials. This program takes the pressure off physicians and allows the clinical trials team to search through the patient database, and if there is a match, contact the patient directly. This presentation explores the journey of bringing PTC to RVH and discusses all the barriers that had to be overcome over the past 5 years. 

4:00 - 4:15     Faculty Q&A


DAY FOUR:

1:00 - 1:45     Health Canada’s Clinical Trial Compliance Program
Asma Syed, MSc, Field Operations Supervisor, Clinical Trials Compliance Program, Health Canada
An overview will be provided of Health Canada’s Clinical Trial Compliance Program, including how the program continued providing oversight during the pandemic, the plan for this fiscal year and program
updates.

1:45 - 2:30    Clinical Trials Regulatory Modernization
Carole Legare, MD, Director, Office of Clinical Trials, Health Canada
Dr. Legare will review the current clinical trial landscape in Canada, current regulations and how Canada is proposing to modernize its clinical trial regulatory framework.

2:30 - 3:15    Health Canada - Device
Marie-Pierre Desrosiers, Scientific Evaluator, Medical Devices Directorate, Health Canada
Alana Hendry, Senior Policy Analyst, Medical Devices Directorate, Health Canada
This presentation will focus on regulatory requirements for Investigational Testing Authorizations (ITA) by Health Canada. An overview of the current Medical Devices Regulations pertaining to Investigational Testing will be presented as well as how Health Canada is proposing to modernize its medical device clinical trials regulations.

3:15 – 3:30     Break

3:30 - 4:00     FDA’s Bioresearch Monitoring Program - Foreign Inspections and Program Updates
CDR Gene Gunn, MSPH, Investigator (Bioresearch Monitoring Specialist), US Food and Drug Administration
CDR Gunn will focus on the FDA’s role in the oversight of clinical trials that are conducted in Canada. Special attention will be paid on what to expect during an FDA inspection.

4:00 - 5:00     Regulatory Body Panel/Q&A
CDR Gene Gunn, MSPH, Investigator (Bioresearch Monitoring Specialist), US Food and Drug Administration
Carole Legare, MD, Director, Office of Clinical Trials, Health Canada
Asma Syed, MSc, Field Operations Supervisor, Clinical Trials Compliance Program, Health Canada
Jérémie Savard, Regulatory Affairs Supervisor, Specialized Licencing and Exemptions Section, Controlled Substances and Cannabis Branch, Health Canada
Mélissa Riverin, Regulatory Affairs Supervisor, Specialized Licencing and Exemptions Section, Controlled Substances and Cannabis Branch, Health Canada
Marie-Pierre Desrosiers, Scientific Evaluator, Bureau of Investigational Testing, Special Access and Post‐Market, Medical Devices Directorate, Health Canada
Alana Hendry, Senior Policy Analyst, Bureau of Policy, International Programs, and Stakeholder Relations, Medical Devices Directorate, Health Canada