Pharmaceutical Regulatory Affairs and Quality Operations
Program Learning Outcomes
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.