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Global Innovation in Manufacturing and CMC
Session Chair(s)
Matt Popkin, PhD
Senior Director, CMC Excellence, Global Regulatory Affairs
GSK, United Kingdom
Evdokia Korakianiti, PhD, MSc
Head of Quality and Safety of Medicines
European Medicines Agency, Netherlands
This session will focus on the global regulatory frameworks for enabling innovation in manufacturing and quality. Innovation includes the development and manufacture of new types of products, new manufacturing platforms, innovative technologies such as model-based controls, the wider scope of and new analytical technologies. The discussion comes at a critical time as the implementation of new digital tools and manufacturing technologies are key to the evolution of manufacturing, which can be enabled by tools such platform technology master files, The session will also reflect on how groups such as the new EMA Quality Innovation Group is seeking to lead the transformation of medicines’ manufacturing in Europe and how this is linked to fast moving initiatives outside of Europe, such as FDA FRAME and platform design technology programs, ICH, and ICMRA collaborative initiatives under the PQKMS umbrella, including collaborative assessments. The discussion will also focus on how collaboration and the identification of risk can already enable technology.
Learning Objective : Describe how decentralised manufacturing (DM) for ATMPs can become a reality in the current regulatory framework. Discuss CMC regulatory hurdles and possible solutions. Present learnings from the development and first roll out of a DM platform.
Speaker(s)
Setting the Scene
Evdokia Korakianiti, PhD, MSc
European Medicines Agency, Netherlands
Head of Quality and Safety of Medicines
EU Perspective on Enabling Innovation in Manufacturing/CMC
Marcel Hoefnagel, DrSc, PhD, MSc
Medicines Evaluation Board , Netherlands
Senior Assessor Biopharmaceuticals
EFPIA Technology Priorities and the Current and Future Frameworks
Matt Popkin, PhD
GSK, United Kingdom
Senior Director, CMC Excellence, Global Regulatory Affairs
When Innovation Meets Regulation: Decentralised Manufacturing for ATMPs and How to Solve CMC Regulatory Challenges
Ursula Busse, PhD, MBA
Tigen Pharma SA, Switzerland
Head of Regulatory Affairs
Artificial Intelligence and Manufacturing Innovation - Opportunities and Challenges
Gert Thurau, DrSc, PhD
F. Hoffmann-La Roche Ltd, Switzerland
Head of Manufacturing Technology Innovation in CMC Regulatory Policy
Panelist
Sau L Lee, PhD
FDA, United States
Deputy Super Office Director, OPQ, CDER
Panelist
Barbara Stubbe
FAGG-AFMPS, Belgium
GMP/GDP Inspector
Panelist
Guenter Waxenecker
Austrian Medicines and Medical Devices Agency (AGES), Austria
Head of the Austrian Medicines and Medical Devices Agency
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