Event Calendar

Canadian Regulations / Inspections

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2018 Agenda

2019 Agenda Coming Soon! 

Saturday, September 29, 8:30 to 9:15        

Negotiating a Reasonable Allocation of Risk in Clinical Trial Agreements (And Why the New mCTA Falls Short)

Negotiating the liability sections of a CTA is often the most challenging task facing CTA negotiators.  Mr. Rajakaruna will identify and describe how to negotiate a reasonable allocation of risk and liabilities for your site. Topics covered will include subject injury reimbursement, indemnification, insurance and limitation of liability. For attendees not involved in CTA negotiations, this presentation may still be of value, especially for study personnel who want to know if the CTA properly protects their interests. 317

Presenter: Marlon Rajakaruna, BA, MBA, LLB, CRCP, Partner, Global & Nat'l Co-Leader of Life Sciences, Dentons

Track: Canadian Regulations / Inspections 

Saturday, September 29, 9:20 to 10:05

Negotiation of Clinical Trial Agreements with Canadian Sites 

Dr. Feldman will focus on Clinical Trial Agreements and requirements Canadian sites expect from sponsors. 319

Presenter: Anat Feldman, PhD, CCRP, Senior Business Development Officer, StemCell Technologies Inc.

Track: Canadian Regulations / Inspections

Saturday, September 29, 10:50 to 11:35         

The Tri-Council Policy Statement: Understanding Canada's "Common Rule" for Human Research

Mr. Letendre will explore the Tri-Council Policy Statement (TCPS) and its application to clinical trials in Canada.  He will present the scope of the TCPS, its application, and how it differs from and how it complements ICH-GCP. 321

Presenter: Martin Letendre, LLB, LLMPresident, ethica Group of Companies 

Track: Canadian Regulations / Inspections


Saturday, September 29, 11:40 to 12:25

Health Canada’s Clinical Trial Compliance Program

An overview will be provided of Health Canada’s Clinical Trial Compliance Program, including compliance trends, program updates, transparency, and Canada’s implementation of ICH E6 (R2).  323

Presenter:  Alicja Kasina, MSc, BPharm, Senior Regulatory Advisor, Clinical Trials Compliance Program, Health Canada 

Track:  Canadian Regulations / Inspections

Saturday, September 29, 1:40 to 2:25     

Participant Recruitment Strategies in the Canadian Clinical Trials Environment 

Recruiting study participants is a critical component of the clinical trial process; it can also be one of the most challenging as well. It is crucial that participant recruitment strategies are well planned and meet protocol requirements including budget, timelines, and awareness of the Canadian regulatory/legislative environment. It is imperative to identify what are the potential challenges for recruitment to a study, including barriers to the participant, as well as recognizing that ‘one size’ strategy does not fit all studies. During this session Ms. Johnston will look at various strategies that offer alternative solutions to the usual recruitment posters but also recognizing the added complexities around privacy with these solutions. 325

Presenter: Lisa Johnston, BSN, RN, CCRP, Clinical Research Facilitator, Ottawa Hospital Research Institute  

Track: Canadian Regulations / Inspections

Saturday, September 29, 2:30 to 3:15                                      

Inspection of A Clinical Investigator: Conducting Clinical Trials in Canada  

Mr. Rashti will explain how FDA selects their clinical study sites in Canada, differences between US and Canadian sites, FDA’s foreign cadre, Bioresearch Monitoring Program, deviations observed in Canadian sites, FDA 483 and Warning Letters, and how to be prepared for the agency audit. 327

Presenter: Mike Rashti, BS, President, BIMO Auditor and Trainer, LLC 

Track: Canadian Regulations / Inspections