PHARMACY 753 : Pharmaceutical Regulatory Affairs
Medical and Health Sciences
2025 Semester Two (1255) (15 POINTS)
Course Prescription
Course Overview
The course aim to synthesize knowledge pertaining to the registration and licensing of pharmaceutical products nationally and internationally and to eectively apply regulatory principles to the introduction of new therapeutic products to the New Zealand and global market.
Capabilities Developed in this Course
| Capability 1: | People and Place |
| Capability 2: | Sustainability |
| Capability 3: | Knowledge and Practice |
| Capability 4: | Critical Thinking |
| Capability 5: | Solution Seeking |
| Capability 6: | Communication |
| Capability 7: | Collaboration |
| Capability 8: | Ethics and Professionalism |
Learning Outcomes
- Identify various types of regulatory documents required for market approval of different pharmaceutical product (Capability 1.1, 3.1, 3.2, 3.3, 4.1 and 5.1)
- Demonstrate an understanding of the role of the various global, regional and national regulatory agencies in the development and regulation of a pharmaceutical and therapeutic product (Capability 3.1, 3.2, 3.3, 4.1, 5.1, 6.1 and 6.2)
- Identify and evaluate various regulatory pathways which assess the safety and efficacy of the product (Capability 3.1, 3.2, 3.3, 4.1, 5.1, 6.1, 6.2, 7.1, 8.1 and 8.2)
- Critically evaluate how various developments and regulatory milestones influences the introduction of a pharmaceutical product to the market (Capability 2.1, 4.1, 5.1, 7.1 and 8.1)
- Analyse, evaluate and present regulatory strategies and pathways for the development of a pharmaceutical and therapeutic product (Capability 2.1, 3.1, 3.2, 3.3, 4.1, 5.1, 6.1, 6.2, 7.1 and 8.2)
Assessments
| Assessment Type | Percentage | Classification |
|---|---|---|
| Quizzes | 25% | Individual Coursework |
| Assignments | 75% | Individual Coursework |
| 2 types | 100% |
| Assessment Type | Learning Outcome Addressed | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | ||||||
| Quizzes | ||||||||||
| Assignments | ||||||||||
Workload Expectations
This course is a standard [15] point course and students are expected to spend 10 hours per week involved in each 15 point course that they are enrolled in. For this course, you can expect approximately 50 hr of online lectures, a 4 hr participation in online discussion using video conferencing tool, 45 hours of reading, self-study and thinking about the content and 50 hours of work on online assignments.
Delivery Mode
Online
Attendance is required at scheduled online activities including discussion sessions to receive credit for the components of the course.
The course will include live online events including group discussions and these will be recorded.
Where possible, study material will be available at course commencement and will be released progressively throughout the course.
This course runs to the University semester timetable and all the associated completion dates and deadlines will apply.
Learning Resources
Course materials are made available in a learning and collaboration tool called Canvas which also includes reading lists and lecture recordings (where available).
Please remember that the recording of any class on a personal device requires the permission of the instructor.
Student Feedback
At the end of every semester students will be invited to give feedback on the course and teaching through a tool called SET or Qualtrics. The lecturers and course co-ordinators will consider all feedback and respond with summaries and actions.
Your feedback helps teachers to improve the course and its delivery for future students.
Class Representatives in each class can take feedback to the department and faculty staff-student consultative committees.
Students feedback on course delivery, content, assessments and format will be considered.
Academic Integrity
The University of Auckland will not tolerate cheating, or assisting others to cheat, and views cheating in coursework, tests and examinations as a serious academic offence. The work that a student submits for grading must be the student's own work, reflecting their learning. Where work from other sources is used, it must be properly acknowledged and referenced. A student's assessed work may be reviewed against electronic source material using computerised detection mechanisms. Upon reasonable request, students may be required to provide an electronic version of their work for computerised review.
Class Representatives
Class representatives are students tasked with representing student issues to departments, faculties, and the wider university. If you have a complaint about this course, please contact your class rep who will know how to raise it in the right channels. See your departmental noticeboard for contact details for your class reps.
Inclusive Learning
All students are asked to discuss any impairment related requirements privately, face to face and/or in written form with the course coordinator, lecturer or tutor.
Student Disability Services also provides support for students with a wide range of impairments, both visible and invisible, to succeed and excel at the University. For more information and contact details, please visit the Student Disability Services’ website http://disability.auckland.ac.nz
Special Circumstances
If your ability to complete assessed coursework is affected by illness or other personal circumstances outside of your control, contact a member of teaching staff as soon as possible before the assessment is due.
If your personal circumstances significantly affect your performance, or preparation, for an exam or eligible written test, refer to the University’s aegrotat or compassionate consideration page https://www.auckland.ac.nz/en/students/academic-information/exams-and-final-results/during-exams/aegrotat-and-compassionate-consideration.html.
This should be done as soon as possible and no later than seven days after the affected test or exam date.
Learning Continuity
In the event of an unexpected disruption we undertake to maintain the continuity and standard of teaching and learning in all your courses throughout the year. If there are unexpected disruptions the University has contingency plans to ensure that access to your course continues and your assessment is fair, and not compromised. Some adjustments may need to be made in emergencies. You will be kept fully informed by your course co-ordinator, and if disruption occurs you should refer to the University Website for information about how to proceed.
Student Charter and Responsibilities
The Student Charter assumes and acknowledges that students are active participants in the learning process and that they have responsibilities to the institution and the international community of scholars. The University expects that students will act at all times in a way that demonstrates respect for the rights of other students and staff so that the learning environment is both safe and productive. For further information visit Student Charter https://www.auckland.ac.nz/en/students/forms-policies-and-guidelines/student-policies-and-guidelines/student-charter.html.
Disclaimer
Elements of this outline may be subject to change. The latest information about the course will be available for enrolled students in Canvas.
In this course you may be asked to submit your coursework assessments digitally. The University reserves the right to conduct scheduled tests and examinations for this course online or through the use of computers or other electronic devices. Where tests or examinations are conducted online remote invigilation arrangements may be used. The final decision on the completion mode for a test or examination, and remote invigilation arrangements where applicable, will be advised to students at least 10 days prior to the scheduled date of the assessment, or in the case of an examination when the examination timetable is published.