Pharmaceutical Regulatory Affairs & Quality Operations (RAQ)

This Seneca program has been validated by the Credential Validation Service as an Ontario College Credential as required by the Ministry of Colleges and Universities.

As a graduate, you will be prepared to reliably demonstrate the ability to:

• Describe the government process within the Canadian health care system and provincial formularies.
• Explain the roles and responsibilities of a regulatory professional in industry.
• Explain the concepts in pharmacoeconomics as they relate to the socioeconomic aspects of health care and health care products.
• Explain Canadian and international health care legislation and regulations.
• Describe international harmonization of regulations and the impact on manufacturing and the submission process.
• Demonstrate information technology skills in the use of software applicable to regulatory affairs submissions, in document and database management systems, and in the use of the Internet for research.
• Explain the Product Development Process.
• Outline the Quality Control Process.
• Define drug, medical device, and biologic submission process requirements.
• Prepare a drug, medical device, and biological submission to the Therapeutic Products Program (TPP) including supplemental documentation.
• Demonstrate the problem solving process as it relates to post-marketing surveillance and pharmacovigilance.
• Demonstrate effective interviewing and negotiating skills in managing the review process.