SCN/CCRM Pre-Event Workshop
Stem Cell Network and CCRM are pleased to offer, in partnership with CellCAN...
Gaps in cell therapy regulation - Where to fit minimally-manipulated cell-based therapies and related processing devices?
Date: Wednesday, 8 March 2017
Time: 8:30 AM - 4:00 PM EST
Location: Westin Montreal, Montreal, Quebec
- Sowmya Viswanathan, University Health Network and University of Toronto
- Julie Fradette, LOEX, CRCHU de Québec-Université Laval, Director of the ThéCell (cell and tissue therapy) FRQS network
- Barbara von Tigerstrom, University of Saskatchewan
Minimally-manipulated autologous cell therapy products are inconsistently regulated in Canada. Currently, it is unclear what criteria shall be applied to determine whether they will be regulated as medical practice, in concordance with the federal Food and Drugs Act. Additional confusion arises because autologous cell therapies may be prepared and used under various circumstances – they may be processed at the bedside using devices, processed in hospital labs, or processed at highly specialized and centralized facilities. Regulatory uncertainty in this area prevents some from moving forward when they should, while it allows others to move forward when perhaps they should not. This workshop will explore these issues and participants will work to develop a set of recommendations for Health Canada’s consideration.
The purpose of this event will be to discuss the current state of regulating minimally-manipulated autologous cell therapy products in Canada and, compare it to other jurisdictions, particularly the US and EU, with the intent of providing specific policy recommendations to Health Canada at the close of the workshop.
The workshop will include:
- Summary of existing regulations (Canada and other jurisdictions) and developments
- Questions for discussion (provided to attendees before the workshop)
- Discussion leading to mutually agreed upon policy recommendations
- Much of the day will consist of informal presentations guided by a moderator
- Patrick Bedford – Manager, Clinical Trials & Regulatory Affairs, CCRM
- Deborah Griffin – Chair, ISCT’s North America Legal and Regulatory Affairs Committee; consultant FACT Consulting Services, Omaha NE
- Olive Sturtevant – Administrative Director for Cell Manipulation Core Facility, Dana Farber Cancer Institute; ISCT’s Designate for FDA’s Cellular Therapy Liaison Meeting and Health Canada’s Cell Therapy Stakeholders Group Bilateral Meeting
- Dr. Maria Cristina Galli – Centre for drug control and evaluation, Istituto Superiore di Sanità, Roma, Italy
- International cell therapy programs
- Cell therapy (manufacture’s and clinicians)
- Blood processing (eg. Canadian Blood Services and/or Hema-Quebec)
- Umbilical cord blood processing
- Processing stromal vascular fractions (eg. Stem Cell Clinics)
- Bone marrow transplantation (Clinicians)
- Cell therapy regulation (eg Health Canada, Academics in health policy)
How to Register to this FREE workshop
Registration is now closed. For information, contact Janetta Bijl.
About Stem Cell Network
Supporting and building Canada’s stem cell and regenerative medicine research sector has been the raison d’etre of the Stem Cell Network (SCN) since its inception in 2001. Its work has been supported by the Government of Canada from the beginning. SCN’s mandate is to act as a catalyst for enabling the translation of stem cell research into clinical applications, commercial products and public policy. In just over 15 years SCN has forged a national community that has transformed stem cell research in Canada, brought research to the point where regenerative medicine is changing clinical practice and established an outstanding international reputation. SCN has pushed the boundaries of what was a basic research area towards translational outcomes for the clinic and marketplace.
Learn more about Stem Cell Network at www.stemcellnetwork.ca
CCRM, a Canadian not-for-profit organization funded by the Government of Canada, the Province of Ontario, and leading academic and industry partners, supports the development of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy. A network of researchers, leading companies, strategic investors and entrepreneurs, CCRM aims to accelerate the translation of scientific discovery into marketable products for patients with specialized teams, funding, and infrastructure. CCRM is the commercialization partner of the Ontario Institute for Regenerative Medicine and the University of Toronto’s Medicine by Design. CCRM is hosted by the University of Toronto.
Learn more about CCRM at www.ccrm.ca