Event Calendar

Canadian Regulations / Inspections

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2019 Agenda

Saturday, September 28, 8:30 to 9:15        

Top 10 Mistakes Commonly Made When Drafting and 
Negotiating CTAs…..What You Need to Know

Top 10 Mistakes Commonly Made When Drafting and Negotiating CTAs…..What You Need to Know

Negotiating a CTA is often a challenging task for CTA negotiators. 

This presentation will identify and describe key mistakes commonly made when drafting and negotiating CTAs. Topics covered will include CTAs with foreign sponsors, CTAs with CROs, privacy, 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. 817

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

Track: Canadian Regulations / Inspections 

Saturday, September 28, 9:20 to 10:05

Health Canada’s New Guide-0100: Helping Researchers to Know the Rules! Follow the Rules!

Health Canada has recently released GUIDE-0100 to help researchers conducting clinical drug trials to be compliant with regulations and guidelines, specifically Part C, Division 5 of the Food and Drug Regulations and ICH E6(R2). This talk will give an overview of the new GUIDE-0100. Methods to integrate Part C, Division 5 and ICH E6(R2) into practice to ensure compliance will be discussed. 819

Presenter: Velma Marzinotto, BScN, RN, CCRP, Senior Research Compliance & Education Specialist, St. Michael’s Hospital

Track: Canadian Regulations / Inspections

Saturday, September 28, 10:50 to 11:35         

Integrating Health Canada Division 5 Requirements with Pharmacy Best Practices

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. This talk 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. 821

Presenter: Jeffrey Doi, HonBSc, BScPharm, RPh, BCPS, Clinical Trials Pharmacist, Princess Margaret Cancer Centre, UHN

Track: Canadian Regulations / Inspections

Saturday, September 28, 11:40 to 12:25

Health Canada’s Clinical Trial Compliance Program

Ms. Kasina will present an overview of Health Canada’s Clinical Trial Compliance Program, including compliance trends, program updates, transparency, Canada’s implementation of ICH E6 (R2) and GUI-0100. 823

Presenter: Alicja Kasina, PhC , MSc, Senior Regulatory Advisor, Clinical Trial and Biological Product Compliance

Presenter: Asma Syed, BSc, Field Supervisor, Clinical Trials Compliance Program, Health Canada 

Track:  Canadian Regulations / Inspections

Saturday, September 28, 1:40 to 2:25     

Conducting an International Trial – The Canadian Sponsor Perspective

The purpose of this presentation is to discuss the structure and processes required to manage an international clinical trial. Ms. Clarke will also review the challenges and successes to date in conducting a clinical trial with a  Canadian site as the sponsor. 825

Presenter: Rosemarie Clarke, BScN, MHM, RN, CCRP, CHE, Research Nurse Manager/Project Manager, University Health Network

Track: Canadian Regulations / Inspections

Saturday, September 28, 2:30 to 3:15                                      

Cross-Border Clinical Trials: Are You Prepared?

Conducting cross-border/international clinical trials increases the complexity of an already complex task exponentially. Key differences in areas such as clinical, regulatory, ethical, and operational, must all be clearly identified as early as possible. Ensuring that these (and more) issues are addressed appropriately across all sites helps secure the rigor of your trial data while simultaneously ensuring participant safety. 827

Presenter: Amr Sharaf, HBSc, CCRP, Clinical Site Monitor, Bristol-Myers Squibb

Track: Canadian Regulations / Inspections