„One Step Ahead - Contamination Control Strategy for ATMPs“
The requirements for European pharmaceutical manufacturers continue to evolve with the ongoing adaptation of the state of the art in the form of the Good Manufacturing Practice Guideline. The entry into force of the updated Annex 1 and its new requirements affect manufacturers of ATMPs like cell and gene therapeutics, indirectly, as the content of the updated Annex 1 is increasingly being inspected via Part IV of the EU GMP Directive.
Manufacturers of blood products are affected, as they are already subject to the stricter requirements of Annex 1. This development is to be expected analogously for ATMPs, as corresponding stricter regulations are already on the horizon.
To facilitate the transition to a future Annex1-based requirement profile for ATMPs like cell and gene therapeutics, we believe that the introduction of a contamination control strategy (CCS) is the key to success.
Key Topics We’ll Cover:
✅ ATMPs – Prepare content from the new Annex 1 now and get a head start
✅ Regulatory classification and outlook – What is the current regulatory situation regarding ATMPs and what is on the horizon in terms of tightening regulations?
✅ Development and documentation of a CCS – Step-by-step recapitulation of a new master document
Who Should Attend?
✅ Quality assurance specialists and managers who are planning a future alignment of their pharmaceutical quality management system according to CCS.
✅ ATMP and cell therapy experts who face a challenge in complying with the new regulations.
Our senior GMP consultants for cell and gene therapeutics will provide you with an overview of current regulatory developments, emerging challenges and promising strategies to overcome them.
🎯 Identifying challenges early means more time to find suitable solutions!
Our webinar will take place on the following two dates. Please select your preferred date here:
June 3rd, 2025 – 11:00-11:30 am (UTC+2)
June 5th, 2025 – 11:00-11:30 am (UTC+2)
📢 In future, we will keep you updated about further regulatory changes relating to CCS on our website and our LinkedIn account!