We are actively seeking two subject matter experts with 3 to 10 years of experience in the pharmaceutical industry, focusing on Canadian regulations, to volunteer for a significant role in updating our "Pharmaceuticals: Canadian Regulations" course.
This crucial educational offering, last updated in 2017, aims to impart foundational regulatory knowledge for pharmaceuticals, radiopharmaceuticals, and biologic products in Canada. Given the rapid evolution of regulatory landscapes, the course requires the insight of seasoned professionals to ensure its content is up-to-date and reflective of current practices and regulations.
Course Overview:
This in-depth course covers essential regulatory aspects, including:
- An overview of the Canadian regulatory framework and legislation for prescription drugs, nonprescription drugs, and natural health products.
- Insight into the organization and function of Health Canada.
- Good Manufacturing Practices (GMPs).
- Processes for submissions, patent listings, compliance, labeling, advertising, promotion, and managing post-approval changes.
Volunteer Role Expectations:
The SMEs will be tasked with:
- Conducting a comprehensive review of the course content to gauge its accuracy and relevancy against the backdrop of current Canadian pharmaceutical regulations.
- Identifying areas in need of updates or overhaul to align with the latest regulatory changes since the last update in 2017.
- Incorporating recent guidelines, legislative amendments, and best practices into the course material.
- Ensuring the course content is thorough and provides actionable insights into navigating Health Canada's regulatory requirements, submission protocols, and post-market procedures.
Volunteer Specifications:
- Professionals with 3 to 10 years of experience in the pharmaceutical industry, particularly in roles related to regulatory affairs or compliance within the Canadian context.
- A deep understanding of Health Canada’s regulatory framework, including submission requirements, GMPs, and post-market surveillance.
- Strong research, analytical, and content development skills.
- A commitment to sharing knowledge and enhancing the professional development of peers in the industry.
Key Details:
- Number of Volunteers Needed: Two
- Incentive: Acknowledgment of contributions and a certificate of appreciation.
This volunteer opportunity offers a unique chance to make a meaningful impact on the pharmaceutical industry's understanding and application of Canadian regulations. Your expertise will contribute significantly to ensuring that the course remains a current and invaluable educational resource.
We invite interested individuals to apply by submitting their resume along with a brief statement of interest, emphasizing their experience with Canadian pharmaceutical regulations and any prior involvement in educational or regulatory projects.
Join us in this critical project to refresh and improve the "Pharmaceuticals: Canadian Regulations" course. We look forward to your expertise and enthusiasm for this initiative!