Registration - Consultant

Subject Matters

• Consumer Issues
• Health
• Industry
• Intellectual Property
• International Relations
• International Trade
• Science and Technology

Subject Matter Details

Policies or Program

• Canada's Food and Consumer Safety Action Plan, specifically proposed legislation and regulation with repect to therapeutic products
• Federal Health Partnership with respect to the coordination of federal drug plan policies and programs
• Food and Drugs Act, specifically with respect to the approval, regulation and life-cycle management of therapeutic products
• Health Canada Blueprint for Renewal: Modernizing Regulatory System for Health Products and Food (formerly Bill C-51)
• National Pharmaceuticals Strategy, particularly with respect to Health Canada policies and programs on a common formulary
• National Pharmaceuticals Strategy, particularly with respect to Health Canada policies and programs on catastrophic drug coverage
• National Pharmaceuticals Strategy, particularly with respect to Health Canada policies and programs on expensive drugs for rare diseases
• National Pharmaceuticals Strategy, particularly with respect to Health Canada policies and programs on pricing and purchasing strategies
• Patent Act as it relates to the regulation of intellectual property for therapeutic products
• Patented Medicines Prices Review Board with respect to amendments to the guidelines for the regulation of pricing of patented drug products patentees
• Patented Medicines Prices Review Board with respect to decisions on the reporting obligations of patented drug products patentees
• Proposed and potential policies with respect to current or potential regulation of cross-border trade in pharmaceuticals, including the Export Control List
• Science and Technology Strategy led by Industry Canada, particularly with respect to the life sciences priority under the S&T Strategy

Regulation

• Food and Drugs Act Regulations with respect to Data Protection under C.08.004.
• Food and Drugs Act Regulations, specficially with respect to approval, regulation and life-cycle management of therapeutic products
• Medical Devices Regulations under the Food and Drugs Act, specifically with respect to the approval, regulation and life cycle management of medical devices
• Patent Act Regulations as they relate to the regulation of intellectual property for therapeutic products, specifically proposed amendments to the Patented Medicines (Notice of Compliance) Regulations.
• Patent Act Regulations as they relate to the regulation of intellectual property for therapeutic products, specifically the Patented Medicines (Notice of Compliance) Regulations.

Communication Techniques

• Written communication
• Oral communication

Government Institutions

• Health Canada (HC)
• Industry Canada
• Patented Medicine Prices Review Board (PMPRB)

Address:
110 COCHRANE ROAD
MARKHAM, ON  L3R 9S1
Canada

Telephone number: 905-940-7164

Client representative

Mark Gilmour, Regulatory Affairs Manager

Parent Company Information