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Round Table Session - Use of Holistic Program Management to Foster Client Vendor Interaction - Closed Session
Session Chair(s)
Stephan Huetter
Senior Manager Regulatory Affairs
PharmaLex GmbH, Germany
Managing and supporting a complete product’s lifecycle requires operational excellence. Whether you’re starting development, navigating Marketing Authorization Application (MAA) / New Drug Application (NDA) submissions, or actively maintaining compliance—there are a lot of moving parts that require constant attention. Regulatory maintenance post-approval is notoriously challenging, as the requirements can differ by region and country and are constantly changing. You not only need up-to-date regulatory intelligence, but the strategic and operational expertise to act quickly and accurately to ensure product compliance. Given all the details, it’s easy to lose oversight caused by siloed thinking. A holistic approach of outsourcing driven by strategic program management approaches could serve you better— saving you precious time to focus on your most urgent needs and targets.
Speaker(s)
Local/ Regional Outsourcing in the EU – Program management as a facilitator to align with many stakeholders and countries
Stephan Huetter
PharmaLex GmbH, Germany
Senior Manager Regulatory Affairs
Global outsourcing – Program management as the backbone for full product responsibility on a global level
Constanze Burkhardt, PHD
Pharmalex, United States
VP, Head of Global Program Management
End-to-End Outsourcing – Program management allowing reducing the client oversight to a minimum?
Laura Monkiene
Pharmalex, Germany
Discussion and Experience Sharing
Christoph Kox
Bayer Consumer Care AG, Switzerland
Head Regulatory Excellence & Operations