SCIENT 721 : Product Development and Regulatory Environments


2022 Semester One (1223) (15 POINTS)

Course Prescription

Aims to give students an understanding of the stages of product development for therapeutics, diagnostics and medical devices, as well as the regulatory requirements affecting product development in the Life Sciences. Project management tools and processes will also be covered in the context of product development.

Course Overview

This course will extend your knowledge of the stages of product development for pharmaceuticals, medical devices and other healthcare products as well as of the regulatory requirements affecting development processes and related commercialisation strategies. Biomedical  sectors are given specific attention given their unique and stringent development requirements. Across a range of seminars, you will learn from industry practitioners, consultants and scientists who have hands-on expertise spanning different dimensions of product development and regulatory affairs within New Zealand and internationally.

Although structured around expert seminars and a workshop, classes are essentially tutorial-based in terms of their style and form of delivery, and students are expected to be active members of the class and be open to asking questions and steering discussion. Throughout the course, the emphasis is on real-world contexts and applied case examples. You will thus gain valuable, practical insights into the challenges of product development within complex regulated environments, and how these are addressed as part of a cohesive, integrated commercialisation strategy.

Course Requirements

No pre-requisites or restrictions

Capabilities Developed in this Course

Capability 1: Disciplinary Knowledge and Practice
Capability 2: Critical Thinking
Capability 3: Solution Seeking
Capability 4: Communication and Engagement
Capability 5: Independence and Integrity

Learning Outcomes

By the end of this course, students will be able to:
  1. Differentiate between the main product development stages for various types of health technology and biotechnology products (Capability 1)
  2. Understand and explain clinical trial and basic regulatory requirements that apply to the various types of products (Capability 1)
  3. Identify and interpret guidelines and other information from regulatory agency websites (Capability 1, 2 and 5)
  4. Recognize how scientific, clinical and regulatory rigour together impact development progress and outcomes (Capability 1, 2 and 4)
  5. Identify and describe some product development challenges and how they have been addressed (Capability 1, 2 and 3)
  6. Interpret and synthesize published literature and other sources of relevant information about the development and commercialization of specified heath technology or biotechnology products (Capability 1, 2, 3, 4 and 5)


Assessment Type Percentage Classification
Assignments 60% Individual Coursework
Presentation 30% Group & Individual Coursework
Class discussions and participation 10% Individual Coursework
Assessment Type Learning Outcome Addressed
1 2 3 4 5 6
Class discussions and participation

Key Topics

Seminar themes include:
  • The regulation of pharmaceuticals, biologics, medical devices, diagnostics and health information technologies (this includes a full day Medical Device Workshop in Week 3)
  • Design / management of clinical trials
  • Strategic and commercial considerations in development and regulatory affairs
  • Development of natural products
  • Early stage development in oncology

Special Requirements

Must complete assignments and group presentation
Must participate in class discussions and Q&A sessions
The course includes a compulsory, full-day workshop on the regulation of medical devices

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 33 hours of classes/seminars, plus a 7 hour workshop in week 3. Outside classes, students are expected to spend up to 2 hours per week on reading and thinking about the content, and around 5-7 hours of work per week on assignments and group preparation.

Delivery Mode

Campus Experience

Attendance is expected at all scheduled activities in order to complete the prescribed components of the course.

The activities for the course are scheduled as a standard weekly timetable.

Our expert speakers request that all information disclosed in their seminars/workshops is used only for learning purposes; class content may contain details that are commercially sensitive. For this reason, classes are not recorded in this course.

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.

Learning resources will be recommended at the start of the course (including book chapters and journal articles). Some further readings may also be provided prior to some weeks' classes.

Student Feedback

During the course Class Representatives in each class can take feedback to the staff responsible for the course and staff-student consultative committees.

At the end of the course 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.

Your feedback helps to improve the course and its delivery for all students.

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 against online source material 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.


The content and delivery of content in this course are protected by copyright. Material belonging to others may have been used in this course and copied by and solely for the educational purposes of the University under license.

You may copy the course content for the purposes of private study or research, but you may not upload onto any third party site, make a further copy or sell, alter or further reproduce or distribute any part of the course content to another person.

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

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

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


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.

Published on 10/11/2021 01:32 p.m.