Research Regulations: Health Canada Updates
The wait is over! Health Canada’s Guide-0100 is finally available. The purpose of Guide-0100 is to help qualified investigators and teams conducting clinical drug trials in Canada to be compliant with the regulations, specifically Part C, Division 5 of the Food and Drug Act and ICH-GCP E6 (R2). Alicja Kasina will provide an overview of the document, including how to integrate Division 5 and ICH-GCP E6 (R2) into practice with the helpful Best Practice portions of the Guide.
- Understand the consultation process of Guide-0100, review, translation and timelines
- Interpret Part C, Division 5 in relation to ICH-GCP E6 (R2) with Canadian Context
- Comprehend the Best Practice tips within the guide to ensure compliance and understanding of the regulations by Qualified Investigators and MD Sub-Investigators
**This session provides continuing education credit for CCRP/ACRP**
Research employees working day-to-day on Health Canada regulated clinical trials and/or industry sponsored clinical trials involving investigational drugs and/or natural health products.
In Person: Royal Bank Theatre, Halifax Infirmary, 1796 Summer St., Halifax.
Online: You will receive an email from the organizer prior to the event to join the session remotely.
Alicja Kasina, Senior Regulatory Advisor, Health Canada
- Tuesday, November 26, 2019
- 12:00pm - 1:00pm
- All Zones
*** BEFORE YOU REGISTER ***
To participate in an online session, you will need to meet the following requirements:
- You must have access to a computer with Skype for Business installed. If you do not have the software, you will be required to install a web app plugin that will allow you to attend as a guest
- You must have an audio output device (headphones or speakers) connected to be able to hear the instructor
- You must have an audio input device (webcam or microphone) connected whether you wish to participate verbally or not. If you do not wish to speak, you may type in the chat window
NSHA Employees: To learn more about Skype for Business, see https://intra.nshealth.ca/training-resources/SitePages/Skype.aspx
External to NSHA: Please join the event as a guest through the link you are sent three hours before the event. We encourage you to ensure you have the Skype for Business Web App installed prior to the event. For help, see: https://support.office.com/en-us/article/join-a-skype-for-business-meeting-with-skype-meetings-app-skype-for-business-web-app-4828ad18-ed21-422a-a870-94d676d4b72a#Version=Skype-for-Business-Web-App.