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Regulatory Literacy Course with weCANreg Inc.
Application Deadline: July 4, 2024
Program Dates: September 9 through December 13, 2024
Time: 1 p.m. ET/10 a.m. PT
Location: Online
Language: English
The application process is closed.
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 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.
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.
SCN is pleased to 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.
Dates & Key Details
Workshop Format and Dates:
Seminar 1 – Orientation & Context
September 9, 2024, 1 p.m.- 3 p.m. ET/10 a.m.- 12 p.m. PT
Guiding question(s):
What is “regulatory affairs”, why do I need a robust strategy, and what are we going to learn about during this program?
Content/key messages:
- Introduction to “regulatory affairs”
- What is it / who does it / when to do it
- How it fits into commercialization (translation to clinical practice)
- Introduction to a Regulatory perspective
- Jurisdictional considerations
- Tools used to accomplish a regulator’s mandate
- Overview of key Canadian Regulations
- Medical Device Regulations
- Transplant Regulations
- Food and Drug Regulations
- Overview of regulatory implementation
- Health Canada Submission Management & Good Review Practices
- A useful framework for putting it together (over time)
Seminar 2 – Product Development & Manufacturing
September 16, 2024, 1 p.m.- 3 p.m. ET/10 a.m.- 12 p.m. PT
Guiding question(s):
What do I need to do to develop and manufacture a viable health product?
Content/key messages:
- Introduction to stage-appropriate product knowledge, criticality assessments & supplier qualification
- How product knowledge should evolve over time, necessitating a phase appropriate strategy
- Why a complex product is only as good as your analytics, necessitating adequate controls and data
- Introduction to a framework for managing product knowledge as it evolves throughout its lifecycle (from discovery through post-market)
- Introduction to data quality
- Why Quality Management Systems (QMS) and basic GxP principles should be considered early
Seminar 3 – Pre-clinical and clinical development
September 23, 2024, 1 p.m.- 3 p.m. ET/10 a.m.- 12 p.m. PT
Guiding question(s):
What studies should I do to “get to the clinic” and what can be done to increase chances of success in FIH studies and beyond “?
Content/key messages:
- Introduction to assessing safety and efficacy
- How to think about preclinical and clinical studies
- Where to get relevant information and guidance
- Overview of key stages leading up to first in human
- Proof of concept considerations
- Balancing in vitro and in vivo plans
- Interpreting guidance and de-risking key investments
- Protocol Development
- FIH studies and beyond
- Overview of what happens before trials begin
- Trial site selection and initiation
- REBs, legal, data management, etc
Seminar 4 – Approaching the regulator
September 30, 2024, 1 p.m.- 3 p.m. ET/10 a.m.- 12 p.m. PT
Guiding question(s):
What will help me have successful regulator interactions/submissions?
Content/key messages:
- Introduction to interactions that can de-risk submissions
- Aligning global regulatory interactions
- Approaching regulators in resubmission meetings
- What regulators expect
- Introduction for communicating with regulators
- Regulatory narratives
- Dos and Do nots
- Overview of drug regulatory submissions
- Format and content considerations
- Planning and issue management
Coaching sessions x4
October 7, 14, 21, and 28, 1 p.m.-2 p.m. ET/10 a.m.- 11 a.m. PT
Mid-term team presentations/ coach feedback sessions
November 1, 2024, 12 p.m.- 3 p.m. ET/9 a.m.- 12 p.m. PT
Coaching session x4
November 11, 18, 25, and Dec 2, 1 p.m.- 2 p.m. ET/10 a.m.- 11 a.m. PT
Final team presentations/ coach feedback sessions
December 13, 2024, 12 p.m.- 3 p.m. ET/9 a.m.- 12 p.m. PT
Workshop Location: Hosted online. A link to the online sessions will be provided to successful applicants.
Please note: This workshop will be delivered in English.
How to Apply
- Due to the interactive nature of this training event, spaces on this online course are limited; all those interested in participating must complete the application form here by 11:59 PM (sender’s time) on July 4, 2024
- Letters of support from the applicant’s supervisor should be emailed directly to trainingSCN@stemcellnetwork.ca by 11:59 PM (sender’s time) on July 4, 2024
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. - The SCN Training & Education Committee will review all complete applications, and applicants will be informed of the competition outcome by early August.
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 trainingSCN@stemcellnetwork.ca for confirmation.
Conditions
- 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.
- 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).
- By accepting a place on this workshop, the recipient agrees to complete a survey 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 SCN reporting to the Government of Canada. By registering for this workshop attendees also accept to have their pictures taken during the workshop and used in materials as described above.
Questions:
For further information on this course or for application related enquiries, please contact trainingSCN@stemcellnetwork.ca.
