About

Join us for an interactive workshop on the practical application of Quality by Design (QbD) and the critical challenges of process comparability and tech transfer of ATMPs.

Since regulations for ATMPs provide a framework rather than a strict checklist, developers must learn to navigate these guidelines. Expert consultants will kick off by aligning the playing field: explaining the essential QbD concepts (TPP, CQAs, process controls) using an established model and discussing how to translate these to the intrinsic variability of ATMPs.

To bridge the gap between theory and clinical reality, hospital pharmacist Bahez Gareb (UMCG) will present a comprehensive set of real-world scenarios. Ranging from cross-border comparability and mid-study vector changes to the current multi-center tech transfer within the Netherlands, he will illustrate the approach, obstacles and lessons learned.

Whether you are a novice looking for a roadmap or an expert facing specific hurdles, this workshop offers actionable insights into the governance, statistics, and practicalities of ATMP development.  

Register here to attend the workshop.

NB: this workshop is for DARE-NL partners only.

Agenda

09:30 – 10:00  |  Walk-in

10:00 – 10:10  |  Introduction & meeting goals
                             Inge Jedema (NKI)

10:10 – 10:50  |  Fundamentals of comparability and Quality by Design
                             Ineke Jonker (Eagle Pharma), Patrick Burger & Sara Melief (3D-PXC)

10:50 – 11:10  | Engineering comparability in early-phase CAR-T: risk-based

                             equivalence in practice
                             Thilo Buck & Frank van Engelenburg (Progress)

11:10 – 11:30  |  Coffee break

11:30 – 12:15  |  Real-world case studies
                              Bahez Gareb (UMCG)

12:15 – 13:00  |  Discussion based on survey input
                              Moderator: Inge Jedema (NKI)

13:00 – 14:00  |  Lunch