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(SOLD OUT) Good Manufacturing Practice Workshop

Description

The number of good manufacturing practice (GMP) facilities is growing in Canada with the rapid progressions in cell therapy. This has created a need for well-trained highly qualified personnel (HQP), as working under GMP conditions and requirements for GMP manipulations are regulated and quite different than in standard research laboratories. In this course, the attendees will learn the essentials of GMP requirements from experts illustrated by several experiences from actual clinical trials. The workshop is a mixture of lectures and hands-on training. Participants will actually perform manipulations according to the GMP standards. Moreover, attendees will have the chance to experience the workflow in a GMP facility and learn how a GMP cell therapy facility is organized. The ongoing regulatory review and what to expect will also be presented and discussed.

When? November 17-18-19, 2019

Where? Centre d’Excellence en Thérapie Cellulaire (CETC) at Maisonneuve-Rosemont Hospital

Registration deadline: October 25, 2019

More information here.

Details
  • 17/11/2019

Webinar Series - Extraneous considerations for manufacturing, Dr. David Courtman

Description

The translation of cell therapies from basic research to clinical trials requires the development of standard operating processes that are both regulatory compliant and of relatively low risk to the quality of the final product. This often requires the careful external sourcing of ancillary materials and services. An appropriate risk analysis needs to be performed to identify and mitigate the risks involved from external suppliers. In early phase trials this may simply involve document review, development of contractual/reporting arrangements, and implementation of an incoming product qualification strategy. As trials progress to later phases external site visits and complete audits may need to be performed to assure the continuous supply of high quality goods and services. I will draw on examples from past academic trials to highlight our experience in implementing these strategies from first in man safety trials to larger efficacy-based studies.

Join us at 12PM. 

Register here. 

Details
  • 21/11/2019

Webinar Series - The Training and Development Challenge, CellCAN & ISCT ESP Committee

Description

ISCT Early Stage Professional (ESP) Committee and CellCAN hosted an impressive discussion around the training and hiring process at the ISCT Regional Meeting in Madison this September. The audience had many questions during the interactive session, and many interesting points were brought up by participants. This webinar session will address the unanswered questions from the live session, as well as the results of the polls answered by the participants during the live event.. Tune in to see how established and early stage professionals answered the surveys.

Join us at 12PM. 

Register here. 

Details
  • 12/12/2019

Webinar Series - Clinical Grade Cords - A new resource, Jason Weiss

Description

More details will be available soon.

Join us at 12PM.

Register here.

Details
  • 16/01/2020

Supply Chain & Logistics for Cell & Gene Therapies - Mastering the 100-metre dash

Description

This free seminar will feature international experts and health care leaders discussing their experiences and solutions to supply chain an logistics challenges for the CGT industry, and sharing key considerations fore the first and last 100 metres to get a treatment to the clinic. Participants will gain an understanding of global issues, the regulatory environment, how product is received on the clinic floor, and the physician's experience. 

When? Monday, January 20, 2020, 8:30 AM to 12:30 PM

Location: Auditorium, Mezzanine Level, 700 University Ave., Toronto

For more information. 

Details
  • 20/01/2020

Webinar Series - Engineered Cell Therapies & Environmental Assessments: CTA Is Just The Start. How To Navigate The New Substance Notification Regulations for Organisms

Description

When it comes time to file a Clinical Trial Application for new cell or gene therapy products, a New Substance Notification Regulation (Organism) Schedule 1 form may also need to be filed with Environment and Climate Control Canada (ECCC). This is often true for products touched by biotech, including vector-modified or gene edited cells, such as CAR-T. But what necessitates the submission of this extra form? Why does it need to go to ECCC, where other forms are sent to Health Canada? And what’s being done to make the CTA process smoother for innovators? Tune in to hear Dr. Sowmya Viswanathan explain her work on clarifying the NSNR(O) process.

Join us at 12PM.

Register here.

Details
  • 20/02/2020

Webinar Series - Bioprinting at the nexus of medical device, biologic and cell therapy regulation, with Sam Wadsworth, Aspect Biosystems

Description

Aspect Biosystems develops 3D-printed structures that incorporate biomaterials, cells, and software. Sam Wadsworth will discuss the various factors that go into regulations of two of their research products: meniscus tissues for knee injury, and pancreatic islet tissue for type I diabetes. Quality control, clinical and non-clinical studies, manufacturing sites, risk mitigation, and supply chain are a few of the issues that will be addressed.

Join us at 12PM (EST).

Register here. 


Details
  • 19/03/2020

2021 Strategic Forum

Description

CellCAN is proud to announce that it will be hosting a third edition of the Cell & Gene Therapy Revolution Strategic Forum in Ottawa, from March 15 to 17, 2021!

More information available here.

Details
  • 15/03/2021

Connect with a network of Canadian researchers, clinicians, regulatory experts and HQP from coast to coast, through our platforms, workshops and events.

13 NETWORK AFFILIATES. 25 PARTNER ORGANIZATIONS. 181 NETWORK COLLABORATORS.