Question

After reading the ICH E2D guidance, discuss the importance of pharmacovigilance in the life cycle management of medicinal products for human use

Answer 1

Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use.

The Importance of Pharmacovigilance.

1. Drug monitoring
2. Pharmaceutical preparations - adverse effects
3. Adverse drug reaction reporting
4. Product surveillance, Postmarketing
5. Legislation, Drug I.Series

Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance