Registration - In-house Corporation

Subject Matters

• Economic Development
• Employment and Training
• Health
• Industry
• Intellectual Property
• Internal Trade
• Research and Development
• Science and Technology

Subject Matter Details

Grant, Contribution or Other Financial Benefit

• Strategic Innovation Fund, as it relates to any initiative submitted or supported.

Legislative Proposal, Bill or Resolution

• Comprehensive Economic Trade Agreement with Europe (CETA) and pharmaceutical intellectual property protection
• Food and Drugs Act Modernization initiative as it relates to reform of drug submission review and approval process
• Food and Drugs Act and Regulations, as they relate to drug export and cross-border trade
• Food and Drugs Act and Regulations, as they relate to the establishment of an approval framework for subsequent entry biologic products
• Food and Drugs Act and Regulations, as they relate to the provision of data exclusivity for innovative drug products
• Food and Drugs Act and Regulations, as they relate to the review and approval of new drug submissions and post market surveillance of drug products
• House of Commons Standing Committee of Health's (HESA) as it relates to Pharmacare, rare disease and/or any other pertinent legislative proposal before the committee
• Patent Act and Patented Medicines (Notice of Compliance) Regulations, as it relates to the regulation of intellectual property, approval for therapeutic products, changes to modernize the Right of Appeal
• Patent Act as it relates to changes affecting term restoration or Canada's Access to Medicines Regime
• Patented Medicines Prices Review Board (PMPRB), as it relates to reporting requirements, pricing guidelines, and dispute resolution
• United States, Mexico, Canada Agreement (USMCA) and pharmaceutical intellectual property protection.

Policies or Program

• Biologics and Genetic Therapies Directorate as it relates to policies affecting the review and approval of submissions
• Clinical Trials environment in Canada: operational issues, investment, enrollment
• Economic Growth Initiatives as it relates to pharmaceutical, clinical trials investment, life sciences industry
• Innovation Agenda - as it relates to the Life Science Industry and the Federal Initiative lead by Innovation, Science, Economic Development
• National Pharmaceutical Strategy and negotiation of the Health Accord, as it relates to National Pharmacare/universal or catastrophic drug coverage, Drug policies & Pricing.
• Pandemic Planning as it relates to the Task Group on Antiviral Prophylaxis recommendations
• Policies related to Subsequent Entry Biologics (SEBs) pertaining to Draft Guidance for Sponsors; Information and Submission requirements for SEBs, regulations and intellectual property policies, naming conventions
• Policies related to rare disease as it relates to separate regulatory pathway for drugs for rare diseases and government strategies.
• Policies related to the importation of pharmaceuticals from Canada to the United States

Policies or Program, Regulation

• Orphan Drug Regulatory Framework as it relates to separate regulatory pathway for drugs for rare diseases

Regulation

• Health Canada/PMPRB proposed regulation changes to the Patented Medicines Regulations.

Communication Techniques

• Written communication
• Oral communication

Government Institutions

• Canadian Institutes of Health Research (CIHR)
• Environment and Climate Change Canada (ECCC)
• Federal Economic Development Agency for Southern Ontario (FedDev)
• Finance Canada (FIN)
• Global Affairs Canada (GAC)
• Health Canada (HC)
• House of Commons
• Innovation, Science and Economic Development Canada (ISED)
• Patented Medicine Prices Review Board (PMPRB)
• Prime Minister's Office (PMO)
• Privy Council Office (PCO)
• Public Health Agency of Canada (PHAC)
• Senate of Canada
• Treasury Board Of Canada Secretariat (TBS)

Address:
7070 Mississauga Road
Mississauga, ON  L5N 5M8
Canada

Telephone number: 905-542-5555
Fax number: 905-542-5689  

Parent Company Information