The implementation of the ICH GCP guideline is scheduled for July by EMA.
The International Council for Harmonization guidelines on Good Clinical Practices will be brought into effect by the European Medicines Agency on July 23, 2025.
AU-TGA eCTD Submission Updates:
TGA has announced updates to Module 1 & Regional Information to the specifications and technical validation criteria transitioning from eCTD AU Module-1 v3.1 to v3.2.
How AI Will Help the Pharmaceutical Industry:
The pharmaceutical industry is one of the most complex and regulated sectors in the world. However, with the rise of artificial intelligence (AI), there’s an incredible opportunity to accelerate processes, lower costs, and ultimately improve patient outcomes. AI is transforming various aspects of the pharmaceutical sector, from drug discovery to clinical trials, and even personalized medicine.
Understanding Periodic Safety Update Reports (PSURs) and Their Importance in Pharmacovigilance
In the world of pharmaceutical regulation, ensuring the ongoing safety of medicinal products post-market approval is just as crucial as during their development. One of the most important documents used to monitor and evaluate the safety of a drug after it hits the market is the Periodic Safety Update Report (PSUR).
Artwork Divisions in Pharmaceutical Packaging
The pharmaceutical packaging industry is complex, highly regulated, and essential to ensuring the safety and efficacy of products. Artwork divisions are a fundamental part of this process, providing the expertise needed to create packaging that is both compliant and effective. From navigating intricate regulatory requirements to understanding the nuances of various pharmaceutical products, artwork divisions contribute significantly to the success of a product in the marketplace.