PRA800 - Regulatory Affairs II

Subject Title
Regulatory Affairs II

Subject Description

This subject focuses on the preparation of a drug submission. Students compile the necessary information and complete the necessary application forms for a CTD New Drug Submission (NDS) Module 1 in electronic format. Submissions and suggestions for dealing with expected deficiencies are both covered. The parameters of a Drug Master file and the Chemistry and Manufacturing Control (CMC) section of a New Drug submission are discussed as well as the actions required when a revision is necessary. The concepts of auditing and the Pre-approval Inspection (PAI) for submission approval are discussed and audit procedures practiced. The basic principles of Pharmaceutical Marketing as it affects drug development and submission compliance are discussed.
 

Credit Status
This is a credit toward the Ontario Graduate Certificate Program in Pharmaceutical Regulatory Affairs and Quality Operations offered through the School of Biological Sciences and Applied Chemistry and the Faculty of Continuing Education and Training.

Learning Outcomes
Upon successful completion of this subject the student will be able to:

1. Explain the CMC for a submission requirements which addresses the required parameters included in an electronic NDS.
2. List the similarities and differences between a Clinical Trial Application (CTA) and Special Access Program (SAP) submission.
3. Research a drug product or Drug Master File for the purposes of a submission strategy.
4. Draft an acceptable analysis of submission needs to support a marketing driven submission change.
5. Prepare an electronic CTD Module 1 New Drug Submission in its entirety including applicable Health Canada forms for a specified product.
6. Analyze a current Health Canada policy, including its implementation and application parameters.
7. Apply pre-submission strategies based on market need as they apply to advanced approval, conditional approval and decision dispute resolution.
8. Explain the regulatory requirements for a Drug Master File and the Chemistry and Manufacturing section of a CTD.
9. Explain the impact of marketing on regulatory affairs pre and post approval
10. Perform a facility inspection, applying the principles of auditing practices.
11. Determine the warranted corrective action for a given facility inspection.

Academic Integrity
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Please visit the Academic Integrity website http://open2.senecac.on.ca/sites/academic-integrity/for-students to understand and learn more about how to prepare and submit work so that it supports academic integrity, and to avoid academic misconduct.

Discrimination/Harassment
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Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Accessibility Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.

Camera Use and Recordings - Synchronous (Live) Classes
Synchronous (live) classes may be delivered in person, in a Flexible Learning space, or online through a Seneca web conferencing platform such as MS Teams or Zoom. Flexible Learning spaces are equipped with cameras, microphones, monitors and speakers that capture and stream instructor and student interactions, providing an in-person experience for students choosing to study online.

Students joining a live class online may be required to have a working camera in order to participate, or for certain activities (e.g. group work, assessments), and high-speed broadband access (e.g. Cable, DSL) is highly recommended. In the event students encounter circumstances that impact their ability to join the platform with their camera on, they should reach out to the professor to discuss. Live classes may be recorded and made available to students to support access to course content and promote student learning and success.

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