May 16, 2017

1. National Union Management Consultation Committee - Drug Manufacturing Inspection Transformation May 16, 2017 Regulatory Operations and Regions Branch

2. Agenda: Program Overview and Context Inspection Transformation Mandate Inspector Engagement Key Initiatives

3. Program Overview The Drug GMP Program is a national program responsible for inspecting drug establishments pursuant to GMP requirements to help ensure that safety and quality standards are met before drugs are sold to Canadians. • The national program comprises 38 GMP inspectors, 4 supervisors, and 2 regional managers. The program encompasses 4 key activities: • Domestic on-site inspections • Foreign on-site inspections • Foreign site evidence reviews (paper based) • Quality Management System

4. Context Complexity of the global drug supply chain is increasing with drug products flowing across international borders… …and the program needs to evolve to help ensure that drug products available to Canadians are safe and of high quality. • About 80% of the drug products Canadians rely on are now imported into Canada • Increasing number of drug products produced from foreign sites in emerging markets with different regulatory systems of oversight than Canada • Multinational companies make decisions that are global in scope, often using outsourced contract manufacturing and packaging/labelling

5. Transformation Mandate To Enhance the Drug GMP Inspection Program to be adaptable to current and future realities by increasing its agility and being more present globally while balancing domestic and foreign establishments’ oversight using a more sophisticated risk-based approach Domestic Global Year 2 of 5 of Transformation Mandate Agile Fixed Cyclical Risk-based Regional National

7. Employee Engagement • Opportunities for employees to participate in program transformation • Forums to identify areas of concern, challenges and offer solutions • Employee engagement sessions held nationally • Continuous engagement through committee membership and briefings Outcomes: 4 key initiatives identified to strengthen inspection processes • Safety and Security • Mobile Technology • Virtual Tools • Training

8. Safety & Security • Safety and Security Training Framework • List of available courses and tools for inspectors • Recorded Webex training sessions are continually accessible • Security Briefing Repository (foreign site inspections) • Developed in consultation with Global Affairs Canada and HC Security Management Division • Integration with operational processes • Revised Standard Operating Procedures and Work Instructions • Administrative procedures to support Inspectors (Contact cards, Consulate Registrations, Green Passports, Visa, etc) • Partnerships - Ongoing collaboration with other federal organizations • Employee Engagement • Ongoing discussions and briefings with employees Initiatives of the Safety and Security working group:

9. Virtual Tools Access and use of appropriate virtual tools is essential: • Strengthen accountability and relationships • Enhance engagement, collaboration and cohesion • Promote regular communication between staff • Facilitate and improve consistency in processes • Gain efficiency and improve program delivery GC Connex Video Conference Teleconference line Promotion of virtual tools available to Program staff • development of information pages related to virtual tools

10. Mobile Technology Creating efficiencies for inspection staff

11. Training Improved formal training framework Development of a sustainability strategy

12. Next Steps: • Year 2 of 5 of the transformation project builds on the initial engagement and initiation of activities conducted in year one • We are building capacity to progress from conception and planning of projects to implementation