Dan Edgcumbe

The Food and Drugs Act, or the Export and Imports Permits Act (Export Control List) or any other legislative and regulatory means in order to protect the Canadian supply of drugs in light of importation legislation in the United States. Pharmaceutical intellectual property protection as it relates to international trade agreements Patent Act as it relates to reporting requirements and pricing guidelines, and the protection of intellectual property in biopharmaceutical products. Monitoring and engaging the Government and Parliamentarians on policies and programs related to Canada's biomanufacturing and life sciences sector strategy Food and Drugs Act updates, as it relate to the reform of clinical trial applications, and drug/device submission review and approval process. Scope includes new drug submissions/indications and post market submissions, reliance & recognition pathways, service standards, fees, biosimilars, clinical trial modernization. Federal Public Drug Plans, with respect to the reimbursement of therapeutic products for Federal plan beneficiaries Standing Committee on Finance (FINA) as it relates to pre-budget consultations. The Department of Innovation, Science and Economic Development and the Innovation Agenda for the life sciences sector: policy or program initiatives to support life science research and development conducted in Canada and manufacturing capability, and as it relates to Canada’s Biomanufacturing and Life Sciences Strategy. Canadian Environmental Protection Act and Regulations in respect of modern, science-based regulations to reflect rapidly changing new technologies. Income Tax Act as it relates to biopharmaceutical industry. Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry, and related updates and to Federal budgetary policy. House of Commons Standing Committee of Industry and Technology (INDU) as it relates to Artificial Intelligence and/or any other pertinent legislative proposal before the committee Patented Medicines Prices Review Board (PMPRB), as it relates to reporting requirements, pricing guidelines, and dispute resolution Economic Growth Initiatives as it relates to pharmaceutical, clinical trials investment, life sciences industry Clinical Trials environment in Canada: operational issues, investment, enrollment