Canadian Regulatory

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2022 Agenda

Thursday, September 15, 2022 at 11:00 am to 11:45 am ET                               Track: Canadian Regulatory 
Liability, IP and Data Issues — A True Investigator-Initiated Clinical Trial Case Study

Mr. Rajakaruna will share his experience working as legal counsel on an international, multi-center, investigator-initiated clinical trial sponsored by a Canadian site. Topics covered will include reviewing contract challenges and examples of potential unfavorable outcomes, options for resolution of issues and opportunities for improvement. In addition, Mr. Rajakaruna will share lessons learned and practice tips. 209

Presenter: Marlon Rajakaruna, BA, MBA, LLB, CRCP, Lawyer, Kingsgate Legal

Thursday , September 15, 2022 at 11:50 am to 12:35 pm ET                                                    Track: Canadian Regulatory 
"Nothing About Us Without Us": Informing Rare Disease Policies in Canada with Patients and Families'' Lived Experience with Rare Genetic Lysosomal Storage Diseases

Canada has lagged behind many countries in terms of developing a coherent national strategy for helping patients with rare diseases (RDs) and for managing the availability of and accessibility to drugs for rare diseases (DRDs). Each province has its own mechanisms for determining which DRDs to cover. This fragmented system leads to delayed and inconsistent access to DRDs. Discussions on whether to implement a pan-Canadian RD framework have been ongoing for more than 25 years. In 2019, the Canadian government announced its intention to establish a national strategy for high-cost DRDs. A detailed plan for this strategy has yet to be developed, however. Canada is thus uniquely positioned to develop an evidence-based, national DRD strategy that learns from national and international approaches that have been used for managing DRDs. Through qualitative semi-structured interviews with 30 Canadians living with RDs, this research answers the following question: How can the lived experiences of patients living with RDs and their families inform the Canadian healthcare system to improve care for patient with rare diseases and access to DRDs? 211
Presenter: Nahya Awada, MSCR, CCRP, Clinical Research Coordinator, Ottawa Hospital Research Institute