PLEASE NOTE: This course has had a change of code - up to and including 2009 it was PHPH9121.

This course consists of two parts that focus on the use of medicines in the post-marketing period.
Part 1 discusses concepts and issues associated with the safety of medicines in the post-marketing period. This area has been gaining widespread prominence recently. There have been numerous recent examples of registered medicines causing unanticipated harm, leading to product withdrawal, legal action and tarnishing the reputations of both the pharmaceutical industry and drug regulators. Objectives include, recognition of the interaction between Consumers (e.g., health care professionals, patients), Pharmaceutical Companies and Regulatory Authorities ; development of a vocabulary and understanding of concepts related to adverse drug reactions, safety data collection, risk management and regulatory requirements; and identification of similarities and differences in international regulatory requirements related to drug safety.

Part 2 of the course addresses Pharmaceutical Information. It discusses the information resources and information services required to bring together and utilise all the information about a drug product which has been generated during its development and marketing. It provides an introduction to and an understanding of the restrictions under which pharmaceutical companies operate in terms of the provision of information, promotion and advertising. Core to this will be an understanding of the requirements of the Product Information and Consumer Medicine Information documents.

Note: This course is a compulsory programmes 5504, 9060.