Articles tagged with “ema”

SmPC Translation: How Errors Lead to Drug Recall Risks

Learn how simple pharmaceutical translation errors in an SmPC or patient leaflet can lead to major drug recalls, regulatory sanctions, and patient safety risks.

45 min read

11/22/2025

pharmaceutical translation smpc drug recall labeling errors regulatory affairs patient safety ema patient information leaflet

A Guide to the EU Clinical Trial Regulation (CTR) & CTIS

Learn about the EU Clinical Trial Regulation (CTR) 536/2014 and the CTIS portal. This guide covers harmonized submission processes, key timelines, and transpare

40 min read

11/19/2025

clinical trial regulation ctr ctis ema regulatory affairs eu regulation 536/2014 drug development clinical trials directive

ALCOA+ Principles: A Guide to GxP Data Integrity

Learn the 9 ALCOA+ principles for GxP data integrity. This complete guide explains each attribute, FDA & EMA regulations, and compliance for pharma and life sci

50 min read

10/31/2025

alcoa+data integrity gxp fda guidance ema good manufacturing practice 21 cfr part 11 regulatory compliance

Navigating Regulatory Compliance in RTSM Systems for Clinical Trials

A comprehensive guide to regulatory requirements and best practices for implementing compliant Randomization and Trial Supply Management (RTSM) systems in clinical trials, covering FDA, EMA, and global standards.

55 min read

4/20/2025

clinical-trials rtsm irt regulatory-compliance fda ema gcp data-integrity validation audit-trails part-11 annex-11