PHARMACY 753 : Pharmaceutical Regulatory Affairs

Medical and Health Sciences

2024 Semester Two (1245) (15 POINTS)

Course Prescription

To synthesise knowledge pertaining to the registration and licensing of pharmaceutical products nationally and internationally and to effectively apply regulatory principles to the introduction of new pharmaceutical products to the New Zealand and global market.

Course Overview

The course aim to synthesize knowledge pertaining to the registration and licensing of pharmaceutical products nationally and internationally and to eectively apply regulatory principles to the introduction of new therapeutic products to the New Zealand and global market.

Course Requirements

No pre-requisites or restrictions

Course Contacts

manisha.sharma@auckland.ac.nz

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
Graduate Profile: Master of Health Sciences

Learning Outcomes

By the end of this course, students will be able to:
  1. 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)
  2. 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)
  3. 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)
  4. 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)
  5. 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 20% Individual Coursework
Assignments 30% Individual Coursework
Final Exam 50% Individual Coursework
Assessment Type Learning Outcome Addressed
1 2 3 4 5
Quizzes
Assignments
Final Exam

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 and/or test preparation

Delivery Mode

Campus Experience

Attendance is expected at scheduled activities including expert sessions. Lectures will be delivered as online recorded lectures which can be accessed by students in their own time but within the recommended time frame. Other learning activities including quizzes, assignments will be made available through Canvas. Attendance on campus is required only for the final exam.
The activities for the course are scheduled as a standard weekly timetable/block delivery.

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.

Based on student feedback the format of the final assessment might be revised in future.

Academic Integrity

The University of Auckland will not tolerate cheating, or assisting others to cheat, and views cheating in coursework 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. This requirement also applies to sources on the internet. A student's assessed work may be reviewed for potential plagiarism or other forms of academic misconduct, using computerised detection mechanisms.

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 course assessment continues to meet the principles of the University’s assessment policy. Some adjustments may need to be made in emergencies. You will be kept fully informed by your course co-ordinator/director, and if disruption occurs you should refer to the university website for information about how to proceed.

The delivery mode may change depending on COVID restrictions. Any changes will be communicated through Canvas.

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 students may be asked to submit 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. In exceptional circumstances changes to elements of this course may be necessary at short notice. Students enrolled in this course will be informed of any such changes and the reasons for them, as soon as possible, through Canvas.