Course Title: Clinical Development of New Medicines
Part A: Course Overview
Course Title: Clinical Development of New Medicines
Credit Points: 12.00
Important Information:
To participate in any RMIT course in-person activities or assessment, you will need to comply with RMIT vaccination requirements which are applicable during the duration of the course. This RMIT requirement includes being vaccinated against COVID-19 or holding a valid medical exemption.
Please read this RMIT Enrolment Procedure as it has important information regarding COVID vaccination and your study at RMIT: https://policies.rmit.edu.au/document/view.php?id=209.
Please read the Student website for additional requirements of in-person attendance: https://www.rmit.edu.au/covid/coming-to-campus
Please check your Canvas course shell closer to when the course starts to see if this course requires mandatory in-person attendance. The delivery method of the course might have to change quickly in response to changes in the local state/national directive regarding in-person course attendance.
Terms
Course Code |
Campus |
Career |
School |
Learning Mode |
Teaching Period(s) |
PHAR1012 |
Bundoora Campus |
Undergraduate |
160H Medical Sciences |
Face-to-Face |
Sem 1 2014, Sem 1 2015 |
PHAR1012 |
Bundoora Campus |
Undergraduate |
173H School of Health and Biomed |
Face-to-Face |
Sem 1 2017, Sem 1 2018, Sem 1 2019, Sem 1 2020, Sem 1 2021, Sem 1 2022 |
Course Coordinator: Dr Celine Valery
Course Coordinator Phone: +61 3 9925 7482
Course Coordinator Email: celine.valery@rmit.edu.au
Course Coordinator Location: 201.08.038
Pre-requisite Courses and Assumed Knowledge and Capabilities
System Enforced Pre-requisites (Enforced by SAMS)
- ONPS2494 Pharmacology of Therapeutic Agents 2 (Course ID 049773)
- CHEM1290 Applied Physicochemical Principles (Course ID 051754)
Course Description
This course develops the knowledge of the clinical development of new medicines and applied understanding necessary for a pharmacist in a drug development career setting. The course has been developed around teaching the competencies within essential domains. These domains are: biologic medicines and biosimilars, new drug targets and pharmacogenomics, clinical trial design, ethics & misconduct, regulation of supply of therapeutic goods, pharmacovigilance, health economics, marketing and medical information.
Objectives/Learning Outcomes/Capability Development
This course contributes to capability development in the following Program Learning Objectives:
- PLO 2. Research, critically evaluate and apply evidence in professional practice
- PLO 3. Demonstrate team and leadership skills to optimise practice
- PLO 7. Apply pharmaceutical, medication and health knowledge and skills to improve patient and population health
Upon successful completion of this course, you should be able to:
- examine clinical evaluation of new and existing drugs and medicines, and post-marketing surveillance.
- evaluate prospects for new approaches in therapeutics.
- apply professional standards in relation to schedules of medicines and controlled substances, PBS registration, advertising, and pharmacovigilance.
- evaluate the influence of manufacture and distribution on product quality with respect to biological safety, bioavailability (including bioequivalence), dosage uniformity and stability
- consolidate team working and leadership skills to optimise practice
Overview of Learning Activities
A number of different learning activities will be used to enable you to develop the required knowledge and capabilities. These include:
- Didactic lectures;
- Problem based tutorials.
Overview of Learning Resources
There are a number of different learning resources to support the teaching and learning activities within this course. These include lecture notes, project templates and links to the relevant Australian Codes and Guidelines.
Overview of Assessment
This course has no hurdle requirements.
Assessment Tasks
Assessment Task 1: Conducting a team project on the development of a new medicine
Weighting 35%
This assessment task supports CLOs 1, 2, 3, 4 & 5
Assessment Task 2: Online quizzes on lecture/workshop material
Weighting 10%
This assessments task supports CLOs 1, 2, 3 & 4
Assessment Task 3: In-semester assessments
Weighting 40%
This assessment task supports CLOs 1, 2, 3 & 4
Assessment Task 4: A written reflection assignment
Weighting 15%
This assessment task supports CLO 5