International Trials and ICH/Canadian


Friday, September 24, 2021 at 1:40 pm to 2:25 pm ET                              Track: International Trials and ICH / Canadian 
The Challenges of the PI/Sponsor in Conducting Investigator-Initiated Trials

In these challenging times, it is still imperative that the PI/sponsor conducts clinical drug trials according to all rules and regulations. Ms. Marzinotto will focus on the roles and responsibilities of the PI/sponsor to ensure that the entire research team can conduct the trial properly. 221

Presenter: Velma Marzinotto, BScN, RN, CCRP, Independent Consultant


Friday, September 24, 2021 at 2:30 pm to 3:15 pm  ET                              Track: International Trials and ICH / Canadian 

Cancelled due to Canadian Election Laws

COVID-19: How Canada Attracted Clinical Trials and Lessons Learned

The COVID-19 pandemic required an urgent search for potential vaccines and treatments in order to limit the impact of its ravaging effects.  Dr. Legare will outline the regulatory and policy measures put in place by Health Canada in order to facilitate COVID-19 clinical trials during the pandemic, challenges experienced by sponsors as well as lessons learned. The impact of this experience on the future of clinical trials in Canada will also be discussed. 223

Presenter: Carole Legare, MD, BSc, CCFP, Cert PE & PV, Director, Office of Clinical Trials, Health Canada


Friday, September 24, 2021 at 3:20 pm to 4:05 pm ET                              Track: International Trials and ICH / Canadian 

Cancelled due to Canadian Election Laws

Health Canada’s Clinical Trial Compliance Program

Ms. Kasina and Dr. Abid will provide an overview of Health Canada’s Clinical Trial Compliance Program, including compliance trends, program updates, inspections of clinical trials during the COVID-19 pandemic. 225

Presenter: Alicja Kasina, PhC, MSc, Sr Regulatory Advisor, Clin Trial & Biologic Comp, Health Canada

Presenter: Hocine Abid, MD, MBA, National Manager, Clinical Trial Compliance Prog, Health Canada


Saturday, September 25, 2021 at 11:20 pm to 12:05 pm ET                              Track: International Trials and ICH / Canadian 
Health Canada Inspection of IITs – An Academic Centre’s Perspective    

The speaker will walk the audience through how they prepared for and facilitated a recent Health Canada Inspection, which was conducted on an investigator initiated trial (IIT) and focused on both Sponsor and Site aspects. The speaker will also share the organization’s inspection experience, lessons learned, and future quality improvement plans. Throughout the presentation, the audience will be encouraged to ask questions and share their own experiences! 529

Presenter: Jennifer Li, BSc, CCRP, Quality Assurance Supervisor, Princess Margaret Cancer Centre