AGENDA
08:30 Breakfast begins
Indulge in a delicious spread while mingling with industry peers and preparing for a morning of enlightenment.
- Sterile products: Annex 1 updates and real world impact on supply chains
- How Annex 1 updates (revision 25 August 2023) have impacted the supply of sterile products into clinical trials
- Compliance gaps and how to approach them
- Review of robotic filling isolator technology
09:15 Dr. Shawn Murtough Ph.D – Director of Quality and Regulatory Services
09:45 Nina Hopkin – Director Clinical Project Management (EU/UK) and Dr Shawn Murtough
- The changing regulatory landscape for clinical trials
- Changes following the introduction of the Clinical Trial Regulation • Transitioning from the Directive to the Regulation
- UK Applications and the Supply Chain Oversight option
10:00-13:00 One-on-One Sessions
Following the presentation, attendees will have the exclusive opportunity to book 15-minute slots with Shawn and also with Nina, head of our project management team. Get personalised insights and answers to your burning questions tailored to your specific project needs.
Whether it’s clarification on regulatory guidelines or strategic advice, our experts are here to provide expert guidance.