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08:30 - 08:50 20 mins
Registration and Morning Coffee
08:50 - 09:00 10 mins
Chairperson's Opening Remarks
09:00 - 12:30 210 mins
Modern CMC Regulatory Strategies and Insights – from Concept to Approval
  • Richard Dennett - Senior Director Regulatory Affairs CMC, PPD

This session provides an overview of modern regulatory CMC strategies which may be selectively applied for a cross range of product classes (e.g. biopharmaceuticals, biologics, advanced therapy medicinal products, biosimilars, vaccines) and how this can be used in consideration for objectively reducing the overall time and cost. This ‘interactive’ session will focus on biopharmaceuticals, biologics, ATMPs, vaccines and biosimilars. Collective team discussions, whiteboard exemplification and workthroughs will be made on key topic points.

12:30 - 13:30 60 mins
Lunch and Networking
13:30 - 17:45 255 mins
Site Visit to the Biotech Training Facility, Leiden
  • Ronald Kompier - Managing Director , Biotech Training Facility, The Netherlands
  • Rebekah Bikker - Marketing and Commercial Manager, Biotech Training Facility
  • Judith van der Zwan - Customer Relations Manager, Biotech Training Facility

Biotech Training Facility (BTF) is a unique training center where people are trained in a real-life pharmaceutical production facility. Good Manufacturing Practices, production operations, process and analytical validations are examples of training topics. The courses contain hands-on training and are key for among others production operators, quality assurance officers, lab technician and maintenance engineers. The facility is also being used as a pilot plant for testing equipment and training on company specific production processes and analytical methods. Biotech Training Facility is completely equipped with cleanrooms, laboratories and a technical area with easily accessible utilities.