8:00-8:30 Registration and Continental Breakfast (provided)
8:45-9:45: Investigational Products
Jeff 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.
9:45-10:30: 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.
10:45 -11:30: 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.
11:30-12:15: 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 3.75 years.
12:15-1:00: Lunch (provided)
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 – 2:15: Break
2:15 – 3:15: Conducting Investigator-Sponsor Trials According to Health Canada’s Guide 100: Everything you need to know
Velma Marzinotto, RN, BScN, CCRP, Senior Research Compliance and Education Specialist, Providence St. Joseph’s St. Michael’s Healthcare
3:15 – 4:15: Clinical Data Management: What You Need to Know
Parveen Dosanjh, BSc, Clinical Data Manager, Everest Clinical Research
Ms. Dosanjh 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.
8:15-8:30 Continental Breakfast (provided)
8:30-9:15: Health Canada’s Clinical Trial Compliance Program
Asma Syed, BSc, Field Supervisor, Clinical Trials Compliance Program, Health Canada
An overview will be provided of Health Canada’s Clinical Trial Compliance Program, including program updates, transparency, Canada’s implementation of ICH E6 (R2), new inspection types and GUI-0100 Interpretation Guide
9:15-10:00: Overview of the Cannabis Research Licence and Analytical Testing Licence Application Process
Health Canada Representitive, Medical Access Directorate within the Controlled Substances and Cannabis Branch
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, Health Canada recently published the Cannabis Licencing Application Guide: Research and the Application requirements for cannabis analytical testing under the Cannabis Act and Cannabis Regulations. 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.
10:00 -10:45: Health Canada - Device
Fatiha Chellat, PhD, A/Manager Investigational Testing Division, Health Canada
Douglas Watson, Health Canada
This presentation will focus on regulatory requirements for Investigational Testing Authorizations (ITA) by Health Canada. The presentation will present an overview of the Medical Devices Regulations pertaining to Investigational Testing and provide information on policies and procedures required for new and revised ITAs.
11:00 – 12:15 ICH E6(R2): Good Clinical Practice
Sandhya Patel, BScN, BSc, Independent Consultant
Ms. Patel presentation will focus on Responsibilities of an Investigator. ICH Guidelines sections 4.1 to 4.13. Sections reviewed will be Qualifications, REB/IRB Investigational Product Safety Reporting Documentation, Time and Resources and Protocol Adherence
12:15-1:15 Lunch (provided)
1:15-2:00: Health Canada Trial Compliance Program
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.
2:00-2:45: FDA’s Bioresearch Monitoring Program - Foreign Inspections and Program Updates
LCDR Gene Gunn, MSPH, Investigator (Bioresearch Monitoring Specialist), US Food and Drug Administration
LCDR 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.
3:15-4:00 Regulatory Body Panel
4:00-4:15 Conference Wrap up and Q&A