Fundamentals of Drug Safety and Pharmacovigilance


The challenge of maximizing drug safety and maintaining public confidence has become increasingly complex. Pharmaceutical and biotechnology companies must not only monitor, but also proactively assess and manage drug risk throughout a product’s lifecycle, from development to post market. 
20th World Conference on Pharmaceutical Chemistry and Drug Design is going to be held in Dubai during September 03-05 2018, under the enclosed title "Pharmacovigilance"

https://drug-chemistry.pharmaceuticalconferences.com/


Pharmacovigilance: WHO defined as 'the pharmacological science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’
An umbrella term used to describe the processes for monitoring and evaluating ADRs is a key component of effective drug regulation systems, clinical practice and public health programs.
It is the study of the safety of marketed drugs examined under the practical conditions of clinical use in large communities.
Drugs appear to be safe and well-tolerated, but the safety in the ‘real world’ is unclear- Chronically/repeatedly use of drugs, Use with other drugs
Safety in vulnerable groups is unknown- Pregnant women & breastfeeding mother, elderly, young children
Significant harm to a few patients, rumors and myths- can destroy the credibility, adherence to and success of a treatment.
Pharmacovigilance provide evidence- medicine-related problems: treatment failure, counterfeit/poor quality medicines, drug interactions, incorrect use.
Generate evidence that will inspire public confidence and trust.

Increase the awareness of healthcare professionals and the public on the understanding of importance of pharmacovigilance, Develop and promote an effective channel for ADR reporting, such as online reporting system, All the parties involved in pharmacovigilance reporting are coordinated under a platform from BPOM , A centralized database for safety reports to facilitate systematic follow up and detailed analyses, Improve communication among stakeholders in the reporting of adverse events such as, the regulator, the health care providers, and manufacturer for pharmacovigilance.

Roza Palv
Program Manager-Pharma Chem 2018


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