|
|||||||||||||||||||||||||||||||||||||||||
Drug Development - 9060 | |||||||||||||||||||||||||||||||||||||||||
The Master of Medical Science in Drug Development will be awarded to students who successfully complete the coursework identified below. The program consists of eight core and four elective courses, delivered mainly by distance learning with some on-campus workshops. It will be taken part time (six sessions) to complete. The elective courses shall be selected from those that are available in the particular session, provided pre-requisite and timetabling constraints are met.
The program is designed for persons wishing to pursue careers that relate to the development and safe use of medicines. Career opportunities exist in the pharmaceutical manufacturing industry, government and in research institutions such as universities. Health care professionals interested in developing new medicines and improving the use of existing medicines will find the course of value. The extensive range of electives enables the candidate to specialise in particular areas such as the discovery of new medicines, regulatory affairs, clinical trials, market development, medical department administration, preclinical studies, etc. To fulfil the program requirements students must satisfactorily complete eight core courses plus four elective courses, each worth 6 units of credit. Program Objectives and Graduate Attributes The discovery, development and marketing of medicines has become a highly organised interdisciplinary team activity. Members of such teams need to be literate in all aspects of drug development ranging from procedures for identifying lead compounds through to the full development of the product including preclinical studies, clinical trials and the legal, regulatory and ethical issues relevant to marketing and on-going vigilance of the medicine. The aim of this course is to enable people working in the field of developing and using pharmaceutical substances to obtain such expertise by providing core and elective materials in a distance-learning format. Since interchange of ideas is an essential part of any educational activity, the course will include interactive assignments with specific tutors and group discussions where students come together for tutorials, workshops and practice sessions, and generally to interchange ideas.
Learning Outcomes Assessment will be based on the ability to apply principles to problem solving. There will be minimal emphasis on memorization 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. Students will also be issued with workbooks for each course that will set out assignment work and other tasks. This will be supported by the on-line learning system, Blackboard, which provides all course information including assignment work, student questions and answers, chat rooms, etc. Students will study the manuals at their own pace within allocated time periods (nine weeks per course). There will be telephone tutorials for each course and two weekend workshops per Session. Tutors will be available for Q&A by email. Program Overview
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. In the final year of the Masters program, students select four elective courses from those offered within the Drug Development suite. This gives students an opportunity to specialise in an area that is of particular interest to them, or where they have no experience and want to broaden their knowledge. Below is a list of core and elective courses for the Master of Medical Science in Drug Development. Generally students must take all core courses and sufficient electives to give a total of 72 units of credit. The program proceeds in three stages, which correspond to Years 1 to 3 for students proceeding in the minimum time. Course Selection Year 1
Session 1 Session 2
Year 2
Session 1 Session 2
Year 3
Session 1 Two Elective Courses are chosen from the following (each 6 units of credit)
Session 2
Two Elective Courses are chosen from the following (each 6 units of credit)
Students may select up to two elective MBA courses to a maximum of 12 UoC from the Australian Graduate School of Management (AGSM). Students should check timetabling of these courses through AGSM.
Please refer to the Program Structure above and contact the school office for further information.
For information regarding fees for UNSW programs, please refer to the following website: https://my.unsw.edu.au/student/fees/FeesMainPage.html
|