Pharmacovigilance registration process timeline for Shudarsana Company
Data elements for reporting serious adverse events occurring in a clinical trial or bio availability or bioequivalence study
Quality Management system at Marketing authorization holder organization
These topic comes under the guidance of Pharmacovigilance: Introduction: This module contains guidance for the establishment and maintenance of quality assured Pv system for MAHs for performing their Pv activities; MAHs shall establish and use quality systems that are adequate and effective for the performance of Pv activities. Structure and processes A Pv system is […]
Collection, Processing & Reporting of Individual Case Safety Reports
The guidance of pharmacovigilance for Marketing authorization holders in India has described the following points regarding collection, processing and reporting of ICSR (individual case safety reports) Under-reporting of AEs/ADRSs is a well-known problem associated with spontaneous reporting, therefore, MAHSs shall have different sources/methods to report AEs/ADRs to the organization. The following sources/methods required to be […]
Periodic Safety Update Report for Pharmacovigilance and safety monitoring
The Indian guidance regarding pharmacovigilance system has given description about the preperation and submission of periodic safety update reports. Introduction: The Periodic Safety Update Report is a document for evaluation of the benefit-risk profile of a pharmaceutical product submitted by the MAH at defined time points as per Drugs and Cosmetics Act, 1940 and Rules thereunder during […]
Pharmacovigilance System Master File for India
The Pharmacovigilance guidance document for Marketing Authorization Holders of Pharmaceutical Products stated following thing regarding Pharmacovigilance System Master file PSMF. Content of PSMF Module 1 1.1 Introduction The CDSCO should make a regulatory decision regarding the safety and efficacy of pharmaceutical goods based on the expert committee’s analysis. The data that surface after the first […]
Pharmacovigilance System of India
Pharmacovigilance system in India The guidance is being provided by the Indian Pharmacopoeia Commission. The Pharmacovigilance Guidance Document for Marketing Authorization Holders for Pharmaceutical Products describes the following points. Objective The purpose of this paper is to support MAHs and other related stakeholders who actively participate in the introduction, dissemination, and delivery of pharmaceutical products […]
