Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance. PV is concerns with the detection, assessment, understanding and prevention of ADRs.
The PV system team obtains valuable additional information, building up the scientific data contained in the original report and making it more informative. This necessitates an utmost requirement for effective regulations of the drug approval process and conscious pre and post approval vigilance of the undesired effects, especially in India. Adverse events reported by PV system potentially benefit to the community due to their proximity to both population and public health practitioners, in terms of language and knowledge, enables easy contact with reporters by electronically.
Topics for this course
BASIC PRINCIPLES OF PV
METHODOLOGIES FOR PV
MODULE II (REGULATIONS IN PV IN CLINICAL RESEARCH)
PV RELATED TOPICS AT THE LEVEL OF ICH
MEDICAL DICTIONARY FOR REGULATORY ACTIVITY
PHARMACOVIGILANCE WORKFLOW IN INDIA
GVP MODULE IV V FDA & EU
PDA OF EV
MODULE III ADR REPORTING
MECHANISMS OF ADVERSE DRUG REACTIONS
SPONTANEOUS REPORTING – UK/FRANCE/US
Module IV (PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES)
RENAL ADVERSE DRUG REACTIONS
DRUG SAFETY IN PREGNANCY
PV IN REDIRECTING
DISEASE PREVALENCE AND DRUG USE IN THE ELDERLY
FATAL MEDICATION ERRORS AND ADVERSE DRUG
RISK MANAGEMENT STRATEGIES EUROPEAN
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