Aug 21, 2024 | Health Canada, N2 News
Health Canada has launched a consultation on its draft guidance document to explain the regulatory requirements for expanded access clinical trials, as they are currently set out in the Food and Drug Regulations, Division 5. Expanded access clinical trials are a type of clinical trial that provides access to investigational drugs that have the potential to treat people living with medical conditions who:
- do not qualify for other clinical trials or
- are not able to participate in one
Please find all information on this consultation at: https://www.canada.ca/en/health-canada/programs/consultation-draft-guidance-expanded-access-clinical-trials.html. The consultation period ends on October 31 and Health Canada will make comments public in a “what was heard” report. A final version of the guidance document is anticipated to be developed as part of Health Canada’s broader clinical trial modernization initiative. Please also note Health Canada will be hosting two webinar information sessions on this draft guidance:
N2’s Rapid Response Team is meeting to finalize its response and is open to feedback from all N2 members. Please send any feedback you’d like to provide to the N2 Rapid Response Team to n2@n2canada.ca by September 22
Aug 19, 2024 | N2 News
N2 is thrilled to share the renewal of the 2024-2025 BC and Québec Provincial Agreements! Since 2017, Clinical Trials BC has funded this agreement to support a skilled workforce for clinical trials, including 24 membership sites and an additional 12 community investigators. Since 2022, CATALIS Québec has been the representative providing Québec with a provincial membership to a network of 32 healthcare institutions to ensure the conduct of high-quality research. N2 has included an overview of each provincial agreement on our website! Take a look at the BC and Québec profiles.
If you are a provincial member and need help accessing N2 tools and resources, please contact N2 at n2@n2canada.ca.
Aug 18, 2024 | N2 News
IMPaCT training awards facilitate participation in a 1-year immersive learning experience with assigned mentors and deliverables. The IMPaCT program is designed to give you the skills and network to design, conduct, and communicate about clinical trials with pregnant people and children (neonates through adolescents).
For the 2025-26 competition there are awards available for:
- PhDs ($35,000)
- Post Doctoral Fellows ($50,000)
- Early Career Researchers ($70,000)
This includes three dedicated awards per year for applicants that identify as Black or Indigenous at any career stage.
Additionally, Health Research BC will co-fund up to three training awards for BC based researchers.
Priority awards will be awarded in the following areas:
Applications will be accepted until 5pm CT on October 18, 2024.
The application form and additional award information can be viewed here: https://www.impactrials.ca/awardinfo
For any questions in regard to the application process or IMPaCT program please contact us at impactrials@gmail.com
Aug 17, 2024 | N2 Committees, N2 News
Dorothy has been the REB Leader at Interior Health (IH) since 2011. Her IH role includes:
- Managing research ethics applications.
- Supporting REB members in their roles.
- Leading the development of policies and SOPs.
She also works closely with REB Administrators from around the province under the partnership agreement shepherded by Michael Smith Health Research BC, including membership in various Communities of Practice and mentoring new REB Administrators. Dorothy joins the N2 REB SOP as a Committee Co-Chair, working with Jacqueline Senych, Director/Manager of Research Ethics from Alberta Innovates.
Aug 15, 2024 | N2 Committees, N2 News
We are excited to announce that Version 4 of the French REB SOPs is now available and posted in the N2 SharePoint Member portal. Thank you to CAREB ACCER and CATALIS Québec, Jacqueline Senych, Dorothy Herbert and the rest of the REB SOP Committee for their support in developing these REB SOPs!
