PharmD Info

A forum for Indian Pharmacy Professionals

List of ICH GCP Guidelines - Safety, Efficacy, Quality and Multidisciplinary Topics,
Forum rules: General rules are applicable for this forum- Find Here
  • User avatar
#5294
ICH guidelines related to Pharmacovigilance are listed below; ICH E2A to E2F guidelines deals with pharmacovigilance.

  • E2a: E2a give guidelines for Clinical Safety Data Management. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development.
    Download Here
  • E2b: E2B guidelines for Data elements transmission of ICSRs (Individual Case Safety Reports). It provides guidelines on clinical safety data management and ICSR data elements transmission.
    Download Here
  • E2c: It provides guidelines on PSURs (Periodic Safety Update Reports) of marketed drugs, which are having role in Periodic benefit risk evaluation report.Download Here
  • E2D: It provides guidelines for Post approval safety data management.
    Download Here
  • E2E: It provides guidelines on Pharmacovigilance planning.
    Download Here
  • E2F: Development Safety Update Report: It provides guidance on DSUR. It is the data from the Investigational drugs in the clinical trials, with or without having a market approval. Sponsors required to submit DSUR on every year.
    Download Here
Similar Topics
Topics Statistics Last post
0 Replies 
450 Views
by Freelancer
ICH E-19 New Guidelines - What's New?
by Admin    - In: ICH-GCP Guidelines
0 Replies 
906 Views
by Admin
FDA SUPAC- IR,MR and SS Guidelines
by Admin    - In: FDA Guidelines
0 Replies 
1538 Views
by Admin
0 Replies 
537 Views
by Admin
IAPT Talking Therapy - Guidelines
by Admin    - In: Treatment Guidelines
0 Replies 
596 Views
by Admin

Embarking on a profession in pharmacy involves no […]

Tamoxifen remains active for up to two weeks after[…]

Pharmacy practice in India is a dynamic and rapidl[…]

PBMs, or Pharmacy Benefit Managers, are businesses[…]

PharmD Info - Highlights