James Cook University Subject Handbook - 2020

PC5520 - Pharmaceutical Public Health - Pharmacovigilance

Subject Description

Drug safety is a significant global issue and pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or other medication or drug-related problems. It has become an integral component of many national public health programs and aims to improve patient care and public health and safety in relation to medicines use and contribute to the assessment of benefit, harm, effectiveness and risk of medicines, thereby encouraging their safe, rational and effective use. This subject subject introduces the student to the concepts, philosophies and practices of pharmacovigilance and their application of a national and international basis.

Learning Outcomes

• demonstrate a mastery and understanding of the principles and philosophies of drug safety and pharmacovigilance
• demonstrate and ability to critically analyse, review and evaluate national and international directives, regulations and guidelines for pharmacovigilance
• demonstrate an ability to critically analyse, review and develop strategies for the establishment of pharmacovigilance programs at a health service or national level

Subject Assessment

• Assignment - (40%)
• Project - (60%)

Note that minor variations might occur due to the continuous subject quality improvement process, and in case of minor variation(s) in assessment details, the Subject Outline represents the latest official information.

Availabilities