Building a bridge: Manufacturing, analytics and trials for translational biomedical researchers workshop
This workshop, hosted jointly by BioCanRx and OIRM, is designed to allow participating teams to develop a feasible and realistic plan for manufacturing and clinical testing of their product or procedure in an early-phase clinical trial. The course will use Good Manufacturing, Laboratory and Clinical Practices (GMP, GLP, GCP) as a framework to provide investigators with a working knowledge of the human, physical, and financial resources required and the timelines needed for clinical translation. The goal is to help investigators translate their discoveries to novel biotherapeutic agents (particularly cells, gene-modified cells, and viruses) for cancer and regenerative medicine applications in an academic setting.
By the end of this workshop, participants will:
- Understand the documentation required and infrastructure resources (human, operational and facilities) required to institute a regulated early-phase clinical trial
- Understand the skill set required in an interdisciplinary team for the effective management of a new drug development program
- Understand the GMP, GLP and GCP requirements to be compliant with Canadian federal regulations for clinical drug development
- Have engaged with a network of experts in the area of GxP and biotherapeutics
Approximately six research groups will be invited to attend the workshop, which will have presentations interspersed with case studies and one-on-one discussion periods with various subject matter experts.
The deadline to apply is May 31, 2019 at 11:59pm EST. More details can be found in the application document downloadable here. Workshop to be held in Ottawa, with support provided by OIRM to cover travel and accommodation costs.
See the workshop schedule at a glance here.