Pharmacovigilance plays a specialized and pivotal role in ensuring safety of medicinal products and health supplements. What are health supplements Dietary or health supplements are substances that addnutrientsto the diet or lower risks of health problems. The supplements available in the market reveal a world of promises and a sea of choices related to nutrition, dieting and bodybuilding. The dosage […]

A comprehensive system can address the need for passive and active identification approaches to medicines-related problems, communicate effectively safety information of medicine to the public, collaborate among various organizations and partners to incorporate pharmacovigilance activities at all health levels. Pharmacovigilance System The pharmacovigilance system efficiently identifies, collects, assesses and communicates medicine-related adverse events to the public in a timely manner. […]

EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is a network for clinical data processing in the European Economic Area (EEA) and a system for assessment and reporting of Suspected Adverse Events (SARs) related to new drug entities during clinical development and marketed products across their life cycle.

The role of Pharmacovigilance is to ensure patients safety by continuously monitoring and preventing adverse reaction of drugs. The rise in pharmacovigilance activities worldwide has resulted in an enormous demand for skilled and trained professionals in the field.

What is Pharmacovigilance Signal Management Process? Implementation of the Signal Management process has aided in continuous improvement of health promotion and protection with clearer roles and responsibilities for safety issue detection .There is increased transparency and increasing use of validated scientific methods with a focus on simplification and increasing the efficiency. The signal management process consists of detection, validation, confirmation, […]

Toxicology is the scientific study of adverse effects that occur in living organisms due to chemicals or biologics. It involves observing and reporting symptoms, mechanisms, detection and treatments of toxic substances, in particular relation to the poisoning of humans. It includes environmental agents and chemical compounds found in nature, as well as pharmaceutical compounds that are synthesized for medical use […]

An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the use of a drug/biologic/medical device/therapy or their combination under normal conditions of use and is suspected to be directly or indirectly related. An ADR will usually require the drug to be discontinued or the dose reduced. Adverse drug reactions (ADRs) have been reported to be among […]