We host a weekly virtual Water Cooler Chat series, where our subject matter experts host informal discussions around a number of clinical supply hot topics. This week we are discussing IMP Supply Chain for QP Release
With an ever-growing market in Europe for both clinical trials and commercial product launches, QP release and its process always need to be planned for at the very beginning of the supply chain. There are many factors to consider when planning an IMP supply chain for successful QP release.
Listen to PCI’s Clinical Quality team discuss how to plan an IMP supply chain for QP release and find out about:
- The QP release process in Germany
- The different QP approaches for different IMP dosage forms (i.e. biologics vs. capsules)
- The different approaches between EUP competent authorities and different QP approaches
- How should staggered EU country approvals for CTAs be managed
- The Brexit effect on QP release in the EU