What is pharmacovigilance PPT?
What is pharmacovigilance PPT?
What is Pharmacovigilance? • Pharmakon (Greek) = Medicinal Substances • Vigilia (Latin) = To keep watch WHO Definition • The science & activities relating to the detection, assessment, understanding & prevention of adverse effects or any other drug related problems.
What is pharmacovigilance PDF?
Pharmacovigilance (PV), is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
What are the types of pharmacovigilance?
There are four important methods in Pharmacovigilance such as,
- Passive surveillance.
- Active surveillance.
- Cohort event monitoring.
- Targeted Clinical Investigations.
What are tools of pharmacovigilance?
Methods and tools used in drug safety analytics and pharmacovigilance analytics
- anomaly -outlier- detection.
- association rule learning.
- principal components analysis.
- affinity grouping.
What is the aim of pharmacovigilance?
The main goal of pharmacovigilance is thus to promote the safe and effective use of health products, in particular by providing timely information about the safety of health products to patients, health-care professionals, and the public.
What is MedDRA in pharmacovigilance?
Abstract. MedDRA (Medical Dictionary tor Regulatory Activities) is a standardised medical terminology, published by the International Council for Harmonisation, used in particular for coding cases of adverse effects in clinical study reports and pharmacovigilance databases, and to facilitate searches in these databases …
What are the principles of pharmacovigilance?
Pharmacovigilance ( PV ) : Pharmacovigilance can be defined as the science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines (i.e. adverse drug reactions or ADRs).
What is the first step in pharmacovigilance?
Medical review is the first level step in signal detection activities.
What are ICH guidelines for pharmacovigilance?
ICH guidelines for pharmacovigilance reporting of adverse drug reactions in the investigational phase of drug development. The ICH has published a number of documents setting standards for safety, both clinical and pre-clinical. Pre-clinical guidelines have an “S” designation e.g. S1, S2 etc.
What is DSUR in pharmacovigilance?
DSURs are new, internationally-harmonized, safety documents (which became mandatory in European Union member states in September 2011) covering the safety summary of medicinal products during their development or clinical trial phase.
What are the main areas of pharmacovigilance?
Activities involved in pharmacovigilance
- Case-control study (Retrospective study).
- Prospective study (Cohort study).
- Population statistics.
- Intensive event report.
- The spontaneous report in the case is the population of the single case report.
What is the process of pharmacovigilance?
Pharmacovigilance (PV) is the process of detecting and monitoring adverse drug reactions (ADR), adverse events (ADE), detecting potential ‘signals’ throughout the drug/medical device lifecycle, and also tracking trends in consumers’ sentiments regarding a particular product (drug/medical device) over time.
What is objective of pharmacovigilance?
The basic objective of pharmacovigilance is the safe use of drugs, patient safety, and, ultimately, safeguarding public health. To achieve this goal, national regulators and international organizations should empower healthcare professionals and the public to report more ADRs.
What is pharmacovigilance and its purpose?
The role of pharmacovigilance is to assess whether the benefits of a drug outweigh the risks and it doesn’t stop after the drugs are certified. PV involves ongoing monitoring of drugs to ensure they remain safe for use, especially since previously undetected adverse events can occur at any time.
What is IRD in PV?
Initial Receipt Date (IRD) The concept of Initial Receipt Date (IRD) is one of the most basic and preliminary learning for pharmacovigilance staff. This is usually well covered during all staff as well as cross functional training.