The Dutch Medicines Act governs, among other things, the manufacture, import, wholesale distribution, marketing, labelling, ...

The European Medicines Agency (EMA) on 1 July released for public consultation two draft guidelines to help sponsors of investigational medicinal products (IMPs) for new drugs and biologics decide ...

This three-and-a-half-day course focuses on the quality systems and the GMP/GCP interface from the Qualified Person or quality leader’s perspective. It focuses on the QP’s duties and challenges in ...

The four new consultations, released Thursday from the European Commission, deal with ethical considerations for pharmaceutical trials with minors, risk proportionate approaches in trials, summaries ...

In this free webinar, learn how centralized IMP labeling workflows can help reduce relabeling risk, rework and study start-up delays. The featured speakers will share practical ways to manage the full ...