DAY 1 – 13 October 2026

08:45 – Morning coffee in Vienna/online meeting room opens
09:00 – Welcome note
09:05 – Introduction & speed networking
09:15 – Overview of International Council for Harmonisation Quality Guidance’s and linkage to Monoclonal Antibody 2026 expectations
10:20 – Break
10:40 – Enhanced pharmaceutical development and Quality by Design
12:00 – Lunch break
13:00 – Process characterisation and qualification of the product and process for BLA/MAA submissions
14:20 – Break
14:40 – Importance of comparability protocols and management of process change within the regulatory framework
15:45 – Case study/exercise and group discussion
16:40 – Discussion & Q&A session
17:00 – End of Day 1

DAY 2 – 14 October 2026

08:45 – Morning coffee in Vienna/online meeting room opens
09:00 – Process control strategy development for clinical and commercial processes
10:20 – Break
10:40 – Analytical product profile and implementation of ICH Q14
12:00 – Lunch break
13:00 – Process qualification, continuous process verification and technology transfer
14:20 – Break
14:40 – Regulatory considerations during product lifecycle
15:45 – Discussion & key takeaways
16:00 – End of training