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. […]
Pharmacovigilance medical writing is providing new job opportunities to personnel with skills in pharmacovigilance, data presentation and medical/scientific writing. The scientific or medical information delivered in this field embraces several disciplines that are service oriented for clinical research and market authorisation.
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 […]
Traditionally in India, the role of pharmacists is confined to pharmacies or hospitals with no specific job profile. But with The Pharmacy Council of India (PCI) recognizing Pharm.D (A Doctor of Pharmacy) course in India, there is an increase in the scope of pharmacy to meet the ever-growing needs of healthcare industry. There are potential non-traditional job opportunities for PharmD […]
Pharmacovigilance, known as drug safety in simpler terms, is related to the detection, assessment, prevention and reporting of adverse reactions that result from the use of medicines. Adverse reaction can be defined as an unintended response to a drug or a medical device that is meant for the diagnosis, prevention and treatment of a disease. Pharmacovigilance educates patients on […]
Pharmacovigilance is the branch of science that deals with the safety of drugs after they have been approved for use. It basically involves identification, evaluation, monitoring and prevention of adverse reactions associated with the usage of drugs. Pharmacovigilance is an important part of clinical research and plays a crucial role in avoiding drug related disasters and toxicity.