Pharmacovigilance (PV) & Good Pharmacovigilance Practices (GVP)

Pharmacovigilance (PV):

The Thalidomide tragedy demonstrated the importance of monitoring drugs after they are released into the market. This tragedy sparked the development of pharmacovigilance, one of the most important aspects of clinical trials.

The WHO defines pharmacovigilance as "science and activities related to the detection, assessment, understanding, and prevention of adverse drug effects or other possible drug-related problems."

It tracks adverse drug reactions (ADRs) and assesses the outcomes to establish the safety of the drugs. It is a study of the effectiveness of commercially available medications as they are put to use in large populations of patients.

?The primary goal of Pharmacovigilance is to:

●??????Detect unknown safety problems early

●??????Identify risk factors

●??????Quantify risk

●??????Prevent patients from unnecessary suffering

Pharmacovigilance uses various methods to generate data for studying adverse reactions. The methods include:

●??????Clinical trial data collection

●??????Spontaneous reporting

●??????Data mining

●??????PSUR (Periodic Safety Update Report)

●??????Intensive reporting

Good Pharmacovigilance Practices (GVP):

?By regularly monitoring, gathering, and disseminating pertinent information to patients, medical professionals, and the general public, appropriate pharmacovigilance practices aim to ensure the safe and effective use of pharmaceutical goods. At any stage of a product's lifetime, regulatory organizations like the FDA, Health Canada, EMA, and MHRA have the authority to perform GVP compliance audits.

You can navigate the audit phase with ease by using sound procedures and processes to collect the necessary data and organize essential requirements. It covers execution, assessment, strategy, infrastructure, and tools.

ADRs are the major concern for the audit team. Here are a few insights on the Management and reporting of ADRs:

●??????Quality Planning

●??????Structured planning to integrate with consistent processes

●??????Quality control

●??????Data verification

●??????Quality assurance

●??????Monitoring and evaluating programs

?Following are the references shared for Good Pharmacovigilance Practices (GVP),

1)???https://www.fda.gov/regulatory-information/search-fda-guidance-documents/good-pharmacovigilance-practices-and-pharmacoepidemiologic-assessment

?2)???https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-i-pharmacovigilance-systems-their-quality-systems_en.pdf