SCN Regulatory Literacy Course with weCANreg Inc.

Stem Cell Network 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 partnering 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: September 22, 2022

Learn more

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.

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.

Workshop Format and Dates

Activity	Date
Seminar 1	October 14th 2022 at 1 PM ET/10 AM PT
Seminar 2	October 21st 2022 at 1 PM ET/10 AM PT
Seminar 3	October 28th 2022 at 1 PM ET/10 AM PT
Seminar 4	November 4th 2022 at 1 PM ET/10 AM PT
Coaching sessions	4 Sessions Between October 31st and November 25th
Mid-term presentations by groups	December 2nd 2022
Coaching session x4	4 Sessions Between December 5, 2022 and January 16th, 2023
Final presentation by groups	January 20th 2023

Workshop Location: Hosted online. A link to the online sessions will be provided to successful applicants.

Application Procedure & Registration Fees

Due to the interactive nature of this training event, spaces on this online course are limited; all those interested in participating must submit a completed application form to attend the Regulatory Literacy Course by September 22, 2022.

A confirmation email will be sent within 24 hours of SCN receiving the submitted application package. If a confirmation email is NOT received from SCN within 24 hours of submission it is the responsibility of the applicant to contact SCN and ensure that the application package has been received by SCN.

Conditions

Spaces are limited on this important training opportunity. SCN will cover the registration costs (paid directly to the organizers) of this course for applicants from their networks who attend all sessions and complete all elements of the online content in this course within the designated period.

Your attendance at each workshop is essential for the program to run effectively and for your own development in the regulatory field. As space is limited and course content relies on interaction between participants, it is critical that you attend all sessions. For every class missed without sufficient explanation, your supervisor will be asked to cover the course cost for that session amounting to $250 per week missed (up to the total course value of $3500).

Eligibility

• Applicants must be a trainee or highly qualified personnel (HQP) (i.e. a graduate student, post-doc, research associate, support staff and/or technician currently working on a research project in the field of stem cells and regenerative medicine in a Canadian lab.)
• If you’re unsure whether you are a trainee/HQP, please email Ellie Arnold at earnold@stemcellnetwork.ca for confirmation.

Workshop Requirements

Note that participants in this course are required to use their own laptop computers, with head-set for audio and webcam for video interaction. A second monitor/screen is also highly recommended.

Application Procedure

1. Complete the application form here by 11:59 PM (sender’s time) on September 22, 2022.
2. Letters of support from the applicant’s supervisor should be emailed directly to earnold@stemcellnetwork.ca by 11:59 PM (sender’s time) on September 22, 2022.
   A confirmation email will be sent within 24 hours of SCN receiving the submitted support letter. If a confirmation email is NOT received from SCN within 24 hours of submission it is the responsibility of the applicant to contact SCN and ensure that the support letter has been received by SCN.
3. The SCN Training & Education Committee will review all complete applications, and applicants will be informed of the competition outcome by September 30, 2022.

Reporting and Communication Requirements

By accepting a place on this course, the recipient agrees to provide a report describing the value of the training and networking opportunities made available through the award. This information will be used at SCN’s discretion on its website, newsletters and for the purpose of reporting to their funding agencies. By registering for this course attendees also accept to have their pictures taken during course and used in materials as described above.

Questions

For further information on this course or for application related enquiries, please contact Ellie Arnold at earnold@stemcellnetwork.ca.