On the 9th of May 2024, NIBRT and Cencora are hosting a learning event entitled ” Navigating the Road to a Successful Annex 1 Inspection”. The session will take place at NIBRT, Foster Avenue, Mount Merrion, Blackrock, Co. Dublin from 8:30AM until 4:30PM, and will help attendees gain valuable insights to ensure future compliance with Annex 1 regulations.
Expected outputs from the event include:
- Insights into the latest updates in EU GMP Annex 1
- Strategies for successful inspection readiness
- Expert guidance on navigating compliance challenges
- Networking opportunities with industry professionals and regulatory authorities
- Tour of the NIBRT, to include the new advanced therapies R&T facility
Event Schedule:
| 08:30-09:00 | Registration: Networking and Breakfast | |
| 09:00 – 09:15 | Welcome Speech | Shada Warreth, NIBRT |
| 09:15 – 10:00 | Annex I Inspection Insights; Best practices for compliance | Ciara Turley, Senior GMP Inspector, HPRA |
| 10:00 – 10:40 | Case Study: Implementation of Annex 1 and regulatory experience post-implementation | Sarah Burke, Sterility Assurance Lead, Sanofi |
| 10:40 – 11:10 | Coffee Break & Networking | |
| 11:10 – 11:45 | ATMP manufacturing and the relevance of Annex I: Useful guidance to help ensuring a safe product | Patrick Nieuwenhuizen, Principal Consultant, Cencora PharmaLex |
| 11:45 – 12:20 | Utilising QRM principles to optimise operator aseptic qualifications in line with Annex I | Eva Pannett, Aseptic Process Lead, Amgen |
| 12:20 – 13:00 | Company Case Study on Annex I implementation | VLE Therapeutics |
| 13:00 – 14:00 | Lunch & Networking | |
| 13:00 – 14:40 | Gap assessments to ensure compliance and how to approach AnnexI | Andrew Hopkins, Director of Compliance, AbbVie |
| 14:40 – 15:15 | Panel Discussion and Attendee Questions | Andrew Hopkins, Director of Compliance, AbbVie Ciara Turley, Senior GMP Inspector, HPRA Patrick Nieuwenhuizen, Principal Consultant, Cencora PharmaLex Conor McMorrow, Takeda Sarah Burke, Sterility Assurance Lead, Sanofi |
| 15:15 – 15:30 | Coffee Break & Networking | |
| 15:15 – 16:30 | NIBRT Tour including the new Cell and Gene Facility |
