What are the software used in pharmacovigilance?

Some software’s used in pharmacovigilance are: Oracle Argus Safety. ArisG. Oracle Adverse Event Reporting System (AERS)

What is pharmacovigilance system?

Pharmacovigilance system involves collection, monitoring , researching upon, assessing and evaluating information received from health care workers such as doctors, dentists, pharmacists, nurses and other health professionals for understanding the adverse drug reaction.

What is pharmacovigilance and why is it important?

Pharmacovigilance ensures the rigorous testing of clinical drugs to improve patient care and reduce the risk of negative side effects. Present throughout the drug lifecycle, PV certifies whether a drug works and if it is safe to use.

What is pharmacovigilance database?

A pharmacovigilance safety database is the central repository for individual case safety reports or ‘ICSRs collected for a company’s medicinal product(s) from all sources globally.

Who art in pharmacovigilance means?

WHO Adverse Reactions Terminology
The WHO Adverse Reactions Terminology (WHOART) is a dictionary meant to serve as a basis for rational coding of adverse reaction terms. The system is maintained by the Uppsala Monitoring Centre (UMC), the World Health Organization Collaborating Centre for International Drug Monitoring.

What are the benefits of pharmacovigilance?

The aims of pharmacovigilance are to: — improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions; — improve public health and safety in relation to the use of medicines; — detect problems related to the use of medicines and communicate the findings in a timely …

What is MedDRA used for?

MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. The terminology is used through the entire regulatory process, from pre- marketing to post-marketing, and for data entry, retrieval, evaluation, and presentation.

What is Argus pharmacovigilance?

Argus Safety Software is a comprehensive platform specialized in solving life sciences industry’s complex pharmacovigilance requirements. Overall, its advanced database helps ensure global regulatory compliance, enables sound safety decisions and integrates safety and risk management functions.

What is the process of Pharmacovigilance?

Pharmacovigilance process Detection: Collection of Individual Case Safety Reports (ICSRs) Assessment Understanding and Prevention of adverse effects

What is the aim of Pharmacovigilance?

Emphasize the importance of pharmacovigilance in every phase of the pharmaceutical industry

Extend support to and collaborate with regulators and other stakeholders to align practices

Develop high-quality training materials to instill a culture of reporting in clinical research

What is pharmacovigilance system master file?

The pharmacovigilance system master file is actually a detailed description of the pharmacovigilance and safety procedures which a company follows when handling a product. It is a very useful document for the regulators and the MAH which ensures that noncompliance issues or deficiencies in the pharmacovigilance system will get detected.

How does pharmacovigilance work?

Pharmacovigilance can only work if there is timely information sharing. The information may come from patients and healthcare providers, as well as other sources such as medical literature. Most countries have reporting mechanisms to their regulatory authorities and drug alert systems.