Medical Affairs is an emerging specialisation within the pharmaceutical industry which is responsible for managing key opinion-leader relationships, publishing data from corporate-sponsored trials, presenting educational information about a product or therapeutic landscape, answering questions from healthcare providers regarding product safety or efficacy that is not addressed in a product's label and supporting research initiatives outside labelled indications for marketed products. This unit will cover the international and local ethical, legal and marketing codes of compliance, quality use of medicines as well as the writing and interpretation of key scientific documents such as product information, consumer medicine information and clinical trial results. Off-label use of medicines and access to unlicensed products will be covered. Product withdrawals will also be discussed. Development of communication skills will be emphasised in this course.
Unit details and rules
Academic unit | Pharmacy |
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Credit points | 6 |
Prerequisites
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None |
Corequisites
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None |
Prohibitions
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None |
Assumed knowledge
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None |
Available to study abroad and exchange students | No |
Teaching staff
Coordinator | Orin Chisholm, orin.chisholm@sydney.edu.au |
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Tutor(s) | Belinda Butcher, belinda.butcher@sydney.edu.au |
Victoria Elegant, victoria.elegant@sydney.edu.au | |
Philip Kwok, philip.kwok@sydney.edu.au |