Articles tagged with “ich-guidelines”

MedDRA & WHODrug: A Guide to Coding in Clinical Trials

Learn how MedDRA and WHODrug standardize coding for adverse events and medications in clinical trials. This guide covers their structure, use, and best practice

30 min read

11/21/2025

meddra whodrug adverse event coding medication coding clinical trials pharmacovigilance data standardization ich guidelines

Managing Protocol Deviations: A Guide for Clinical Trials

Learn how to manage protocol deviations in clinical trials. This guide covers classification, reporting, and prevention to ensure data integrity and GCP complia

40 min read

11/20/2025

protocol deviation clinical trials good clinical practice (gcp)data integrity fda guidance protocol compliance ich guidelines protocol violation

ICH Q8 Explained: A Guide to Pharmaceutical Development & QbD

Learn about the ICH Q8 guideline for pharmaceutical development. This in-depth guide explains Quality by Design (QbD), QTPP, CQAs, and the design space concept.

40 min read

11/15/2025

ich q8 quality by design qbd pharmaceutical development design space qtpp critical quality attributes ich guidelines control strategy ctd module 3.2.p.2

Guide to ICH Q7, Q8, & Q9: GMP, QbD, and QRM Standards

A comprehensive 2025 guide to ICH Q7, Q8, & Q9. Learn the core principles of GMP for APIs (Q7), Quality by Design/QbD (Q8), and Quality Risk Management/QRM (Q9)

30 min read

11/14/2025

ich q7 q8 q9 quality by design (qbd)quality risk management (qrm)gmp for api pharmaceutical quality ich guidelines regulatory compliance

An Overview of Pharmacovigilance (PV) Software Systems

This article provides a technical overview of pharmacovigilance software, detailing core functions, regulatory compliance, and a comparison of leading platforms.

95 min read

8/28/2025

pharmacovigilance drug safety regulatory compliance adverse event reporting pv software oracle argus meddra ich guidelines