What do you mean by pharmacovigilence in drug development process ?

 It is the mission of pharmaceutical research companies to take the path from understanding a disease to bringing a safe and effective new treatment to patients. the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem.

Pharmacovigilance is defined as the detection, assessment and prevention of adverse drug reactions in humans.


It is the process of:

• Monitoring medicines as used in everyday practice to identify previously unrecognised adverse effects or changes in the patterns of their adverse effects
• Assessing the risks and benefits of medicines in order to determine what action, if any, is necessary to improve their safe use
• Providing information to users to optimise safe and effective use of medicines
• Monitoring the impact of any action taken

Scientists work to piece together the basic causes of disease at the level of genes, proteins and cells. Out of this understanding emerge “targets,” which potential new drugs might be able to affect Researchers work to validate these targets, discover the right molecule (potential drug) to interact with the target chosen, test the new compound in the lab and clinic for safety and efficacy and gain approval and get the new drug into the hands of doctors and patients. This whole process takes an average of 10-15 years.

Author: Susmitha Pandarinath, Pharmacist, Certified Pharmacovigilance Professional.