
Pharmaceutical Medicine - 5504
Program Summary
Faculty: Faculty of Medicine
Contact: drugdev@unsw.edu.au
Campus: Sydney
Career: Postgraduate
Typical UOC Per Semester: 12
Min UOC Per Semester: 6
Max UOC Per Semester: 27
Min UOC For Award: 48
Award(s):
Graduate Diploma in Pharmaceutical Medicine
View program information for previous years
Program Description
Health care professionals interested in developing new medicines and improving the use of existing medicines will find the program of value. The extensive range of electives enables the candidate to focus in particular areas such as the discovery of new medicines; regulatory affairs; clinical trials; market development; preclinical studies, etc.
To fulfil the program requirements, students must satisfactorily complete two core courses and six elective courses each worth 6 units of credit.
Program Objectives and Graduate Attributes
Assessment will be based on the ability to apply principles to problem solving. There will be minimal emphasis on memorisation of factual material. Both written exams and assignments will be based on scenarios i.e. case-type situations that require the exercise of comprehension, judgement, and an understanding of the issues involved.
Education and Assessment
Will be based on high-quality information delivery, application of this information through assignment work, and written examinations. This will form the platform for the assignment work that will be based mainly on the primary (i.e. research) literature. A key feature of assignment work will be development of critical appraisal skills for research papers. This will be supported by the on-line learning system, Moodle which provides all course information including assignment work, student questions and answers, chat rooms, etc. Students will study course materials at their own pace within semester. There will be webinars for each course and two weekend workshops per Session. Tutors will be available for Q&A by email.
Program Structure
In the first year of study, the courses within the program start with a general overview of the drug development process, with a focus on drug discovery, chemistry relevant to drug discovery and development issues, pharmacokinetics and codes of practices and standards, and regulation of medicines in Australia. Significant attention is given to understanding the pharmacology and pharmacodynamic properties of drugs and how this relates to pharmacokinetics also. This is explored further in drug safety assessments leading up to the first human clinical testing. As the story of development of a drug from discovery through to human testing progresses in the program we deal with the important principles of clinical trial practice and management. This includes protocol development, obtaining regulatory and ethical approval, planning trial recruitment, data management and data reporting. The course closes with an introduction to the Law as it pertains to the development of new drugs. Emphasis is upon Administrative Law as it applies to the review of regulatory decisions provided by the Therapeutic Goods Act. The processes involved in the regulation of medicines, including prescription and non-prescription medicines, and medical devices within Australia are discussed in detail, along with the requirements of other international agencies.
In the second year of the program, students examine issues related to the formulation of new medicines, with a strong focus on quality of product, examination of impurities and stability of the new medicine. The program also includes methods of assessment and prevention of adverse events, reporting responsibilities and the use of safety information databases. Protection of intellectual property relevant to the industry is examined. Students conclude their program by examining the use of statistics in design of clinical trials and assessment of data, and the importance of decision making throughout the drug development process.
Session 1
- PHAR9102 Pharmaceutical Dev. of Meds (6 UOC)
- PHAR9103 Biostatistics and Trial Design (6 UOC)
- PHAR9107 Therapeutics & Molec Basis of (6 UOC)
- PHAR9108 Therapeutic Basis of Drug Use (6 UOC)
- PHAR9109 Therapeutic Basis of Drug Use (6 UOC)
- PHAR9111 Pharmaceutical Formulation 2 (6 UOC)
- PHAR9112 Advanced Pharmacokinetics (6 UOC)
- PHAR9113 Advanced Regulatory Affairs (6 UOC)
- PHAR9114 Pharmacoeconomics (6 UOC)
- PHAR9116 Advanced Clinical Trials Mgmt (6 UOC)
- PHAR9118 Therap&Molec Basis of Disease2 (6 UOC)
- PHAR9120 Clinical Development of Med (6 UOC)
- PHAR9121 Postmarketing Compliance Meds (6 UOC)
- PHAR9127 Safety and Efficacy (6 UOC)
- PHAR9128 R & D (6 UOC)
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