Ensuring adequate safety standards for all medicines and continual monitoring to ensure their ongoing safety and quality requires expert scientific and technical advice and routine safety reviews. Usually the regulatory authority employs expert scientific and technical advisors to investigate, evaluate and make judgements about safety, risk management and other matters concerning what is known as pharmacovigilance.
Pharmacovigilance is the science relating to the detection, assessment, understanding and prevention of the adverse effects of medicines. When effectively applied can minimise risks and meet our primary directive which is to prevent harm to the patient.
Science and activities for:
- Understanding and prevention of adverse effects or any other drug related problem
- Adverse drug reaction reporting
- Communication of information to HCPs
- Regulatory compliance – willingness to comply
- Consumer information
- Known interactions with other medicinal products
- Pregnancy and lactation
- Effects on ability to drive and use machines
- Undesirable effects