Health Canada Implementation of ICH E8(R1), Special Access Inspection Strategy, and Quality Risk Management
New Article Unit: Clinical Trials BC
Clinical Trials BC’s Activities Report: 2020-2021
Clinical Trials BC’s September 2020 – August 2021 Activities Report is now available. Continue reading “Clinical Trials BC’s Activities Report: 2020-2021”
Our Unit Director Talks Clinical Trials with Chatelaine Magazine
In an interview with the Canadian women’s magazine “Chatelaine,” Alison Orth discusses the important role of clinical trials in “finding new ways to detect, diagnose, and treat diseases”. Continue reading “Our Unit Director Talks Clinical Trials with Chatelaine Magazine”
Nominations Now Open for Clinical Trials BC Awards 2022
The BC clinical trials research community, research teams, stakeholders and patient partners are contributing in magnificent and different ways to the health and well-being of British Columbians. Continue reading “Nominations Now Open for Clinical Trials BC Awards 2022”
Regulatory update: Fall 2021
This edition brings you very exciting news from the International Council for Harmonization (ICH) and at the national level, an update on Health Canada’s Regulatory Modernization Initiative.
ASK JEAN: Do I Need Documented Training on Division 5?
Is it necessary to train and document training on Division 5 Part C (Health Canada Food and Drug Regulations) if you are working in Clinical Trials but have already trained in GCP?
Continue reading “ASK JEAN: Do I Need Documented Training on Division 5?”
ICH E8(R1) Guideline Reaches Approval
Clinical Trials BC shares that The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has approved the revised version of the primary efficacy document known as ‘General Considerations in Clinical Trials’. Continue reading “ICH E8(R1) Guideline Reaches Approval”
Advancing Pragmatic Clinical Trials to Support Learning Health Systems: Opportunities for BC
We brought together key partners at Clinical Trials BC’s Modernization of Clinical Trials symposium to discuss how to enhance capacity for pragmatic clinical trials in the BC health system landscape.
Gavin Stuart: Bringing international expertise to BC clinical trials
Dr. Stuart’s worldwide experience in governance has been of great value to the development of Clinical Trials BC (CTBC) as a fully-operational unit.
Continue reading “Gavin Stuart: Bringing international expertise to BC clinical trials”
BC Health Data Platform Pioneer: Victor Espinosa and REDCap
While not officially a member of the staff team, Victor Espinosa’s accomplishments are noticeable in most of the work of the overall BC AHSN organization, as well as in the health research landscape across the province.
Continue reading “BC Health Data Platform Pioneer: Victor Espinosa and REDCap”