Pharmaceutical & Medical Device Training on SpacedEd

This is a course designed for those planning to work in the area of Pharmacovigilance (PV) or wish to prime up their knowledge on the subject.

Pharmacovigilance (abbreviated PV or PhV) is the science relating to the detection, assessment, and understanding  of adverse effects, particularly short and short long term side effects of medicines. It involves collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects noted as a result of medication (biological products, herbalism and traditional medicines) .

This is a primmer. The full course is being developed.

Pharmacovigilance (abbreviated PV or PhV) is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. Generally speaking, pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to:

• identifying new information about hazards associated with medicines
• preventing harm to patients.

The etymological roots are: pharmakon (Greek), “drug;” and vigilare (Latin), “to keep awake or alert, to keep watch.”

Pharmacovigilance is particularly concerned with adverse drug reactions, or ADRs, which are officially described as: "A response to a drug which is noxious and unintended, and which occurs at doses normally used… for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function."

Pharmacovigilance is gaining importance for doctors and scientists as the number of stories in the mass media of drug recalls increases.

Because clinical trials involve several thousand patients at most; less common side effects and ADRs are often unknown at the time a drug enters the market. Even very severe ADRs such as liver damage are often undetected because study populations are small. Postmarketing pharmacovigilance uses tools such as data mining and investigation of case reports to identify the relationships between drugs and ADRs.

Those wishing to develop understanding of pharmacovigilance. A refresher course for those already involved in pharmacovigilance.