Managing Drug Safety is carried out for following Product Categories;
Pharmaceutical Prescription Medicine
The law defines a medicine as having to have a physiological effect on the body, whether it is used to prevent, treat or diagnose conditions or interfering with the normal operation of the body.
Pharmacovigilance in clinical trials – handling SUSARs during trials; annual reports; safety management in interventional and non- interventional studies.
The term ‘medical device’ covers all products used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability. The range of products is very wide: it includes contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines; surgical instruments and syringes; wheelchairs and walking frames or other assistive technology products – many thousands of items used each and every day by healthcare providers and patients.