Pre-Con Workshop Day (27th April 2026)Monday, 27 April 2026 - CET/CEST (Cent Europe Summer, GMT+2)

Breaking down departmental silos with cross-functional dialogue to answer:

• The ICH Q13 Reality: how is the new guidance practically impacting process development, validation strategies, and regulatory filings?

• Is the "digital twin" a practical tool for today or an expensive dream for tomorrow?

• What is the first, most valuable step a company can take to leverage predictive modelling for continuous or intensified processes?

• What is the single biggest organizational or cultural change required to successfully adopt continuous manufacturing?

• How do we build and train the workforce of the future?

• Beyond monoclonals, what will be the killer application for continuous processing in the next 5 years – Cell & Gene Therapies, vaccines, or other novel modalities?

• Device Integration: Connecting formulation science with patient-centric delivery systems. How do you design a formulation for an auto-injector from day one?

• Aseptic Processing: How to approach and maintain aseptic conditions throughout final fill-finish stages to enhance safety?

• Make vs. Buy: A strategic framework for navigating the fill-finish CDMO landscape. When should you build capacity, and how do you select the right partner?  

• The Regulatory Horizon: Preparing for future expectations in aseptic processing, data integrity, and the use of AI in manufacturing.  

• Sustainability: Addressing the growing need for sustainable and PFAS-free consumables in fill-finish operations.