Topic Description: Planning your IMP Supply Chain for Successful 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.
On Thursday July 30 at 7am PT/10am ET/4pm CET (please note the earlier start time for this session), PCI’s Clinical Quality team will walk through how to plan an IMP supply chain for successful QP release including:
- 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
To register for this event, please click here: