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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, PharmD
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, PharmD
Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
EU Perspective on Enabling Innovation in Manufacturing/CMC
Marcel Hoefnagel, DRSc, PhD, MSc
Senior Assessor Biopharmaceuticals, Medicines Evaluation Board , Netherlands
EFPIA Technology Priorities and the Current and Future Frameworks
Matt Popkin, PhD
Senior Director, CMC Excellence, Global Regulatory Affairs, GSK, United Kingdom
When Innovation Meets Regulation: Decentralised Manufacturing for ATMPs and How to Solve CMC Regulatory Challenges
Ursula Busse, PhD, MBA
CMC Regulatory Affairs Advisor, Self employed, France
Artificial Intelligence and Manufacturing Innovation - Opportunities and Challenges
Gert Thurau, PhD
Head of CMC Regulatory Policy for Manufacturing Technology Innovation in , F. Hoffmann-La Roche Ltd, Switzerland
Panelist
Sau Lee, PhD
Deputy Super Office Director, OPQ, CDER, FDA, United States
Panelist
Barbara Stubbe
GMP/GDP Inspector, FAGG-AFMPS, Belgium
Panelist
Guenter Waxenecker
Head of the Austrian Medicines and Medical Devices Agency, Austrian Medicines and Medical Devices Agency (AGES), Austria
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