Handbook

Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.  This course will cover the identification and quantification of risk associated with medicines,  recognition and interpretation of adverse drug reactions (ADRs) and their underlying toxicopathology and pharmacology and the regulatory requirements for pre-clinical testing including toxicity studies. Students will learns to write and interpret a number of documents associated with pharmacovigilance including Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Report (PBRER), Development Safety Update Reports (DSURs). The international and Australian guidelines for adverse event reporting, international (ICH) guidelines, European and US PV systems, the role of the qualified person and compliance will be addressed in the course.