SCN – Regulatory Literacy Course with weCANreg Inc.
The Stem Cell Network (SCN) researchers have developed core technologies that can significantly alter lives; however, cell therapies are notoriously difficult to translate from discovery to early phase clinical trials and beyond. Furthermore, Canada’s start-up ecosystem lacks regulatory professionals capable of providing long-term strategic regulatory advice because most only have early trial knowledge.
SCN and weCANreg are excited to again partner to deliver the Regulatory Literacy Course, which will augment the SCN community by leveraging weCANreg’s network of experienced regulatory professionals and library of materials to deliver seminars, support meetings, and presentation opportunities for participating trainees. Prepared with a breadth and depth of government, industry, and early academic/start-up regulatory experiences focused on emerging biotechnologies (especially cell & gene therapies), weCANreg is uniquely positioned to provide strategic regulatory advice and identify target milestones/timelines, regulatory opportunities, and potential challenges/risk mitigation options.
Participants in the program will receive tailored project support from weCANreg through (1) a series of four educational seminars; (2) semi-monthly support meetings; and (3) quarterly and final session report presentations delivered to weCANreg coaches and course participants.
Application Deadline: June 19, 2024
Program Dates: September 9 through December 13, 2024
Time: 1 p.m. ET/10 a.m. PT
Location: Online
Language: English
Learning Objective
Participants will learn/demonstrate fundamental knowledge about regulatory strategy, safety, quality, and/or efficacy by working in teams with weCANreg Coaches on case studies designed to have practical utility for the participants.
Please note: the time commitment for this course is approximately 26 hours of instruction.
Who Should Attend?
Eligible groups include graduate students, postdoctoral fellows and research support staff (including technical staff, clinical support staff, research support staff, and other team members who may be centrally involved in preparing regulatory submissions). Participants should be working on projects in the field of stem cells and regenerative medicine in a Canadian lab.
SCN will offer a Certificate of Completion for this event. To be eligible to receive a certificate, participants must:
- Attend the entire workshop; and
- Complete the post-event survey.
Please note: The Certification of Completion is a document demonstrating your attendance at a training event. It is not a credential, as it is not issued based on proof of learning or knowledge attainment.