Location: Novotel Madrid Center – Madrid, Spain
Date: March 11-12, 2020
Catalent Expert Speaking Presentations:
Date March 12th, 09:30 AM (Innovation and Technology Stream)
Title: Beyond Brexit: What Now for Clinical Supply Services across Europe?
Presenter: Paul Ingram, Ph.D. Global Director, Strategic Development and Innovation, Clinical Supply Services
Synopsis: After 3 years of Brexit withdrawal negotiations, the UK is officially no longer a member of the European Union. Clinical sponsors with active and planned studies in the EU and UK can be reassured that the UK will remain part of the current trade arrangements, customs union and single market until the end of the transition period on December 31, 2020. Although future change is certain after the transition period ends, clinical sponsors now have a clearer vision of what strategic options are available so that they may continue to run trials in the UK and EU. This session will explore the early analysis of potential Brexit challenges that sponsors face and the strategic solutions that can support sponsors in a post-BREXIT world.
Date March 12th, 10:30 AM (CTS Operations Stream)
Title: How Thoughtful Protocol Design Can Reduce Comparator Sourcing Cost, Timelines, Complexity & Risk
Presenter: Keith Krenitsky, Global Director, Commercial Drug Sourcing
Synopsis: Clinical trial protocol design can have a significant impact on the cost, complexity, risk and timing of sourcing commercial drug for comparative studies. This session will focus on why early input into the protocol design can be critical and understanding the appropriate level of detail to include in the study protocol to help avoid common sourcing issues later on.