Join us in Tokyo for an exclusive evening of regulatory insights and professional connection.
Explore the latest EU/UK regulatory changes and gain a deep understanding of Qualified Person (QP) responsibilities in clinical programs. Shawn Murtough, an industry expert, will guide you through evolving compliance landscapes and supply chain strategies. Then, enjoy relaxed networking with PCI Pharma Services over food and drinks with panoramic city views.
July 30th, 2025: 4pm - 8pm
4pm-6pm: Presentations by Shawn Murtough
Session 1: Navigating the EU/UK Clinical QP process
- Supply Chain Audits
- QP Declaration
- PSF requirements
- QP Certification requirements
- Managing regulatory changes
- Shelf life extension
Session 2: EU and UK regulatory updates
- The changing regulatory landscape for clinical trails
- Changes following the introduction of the Clinical Trial Regulation
- UK Applications and the Supply Chain Oversight option
- Sterile products: Annex 1 updates and real world impact on supply chains
- Annex 1 Compliance gaps and how to approach them