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Innovation in Manufacturing Globally
Session Chair(s)
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, 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. These technologies can be integral to ensuring quality and supporting a robust supply of medicines. The session will also reflect on how Regulators in EU and US are seeking to support the transformation of medicines’ manufacturing and how regional initiatives link to global platforms like ICH, PICs and ICMRA collaborative initiatives under the PQKMS umbrella.
Learning Objective : Describe the initiatives that regulators take to support the rapid technological growth in medicines manufacture that offers opportunities for better quality of medicines and increased robustness in supply chains leading to increased medicine availability.
Speaker(s)
Celeste Frankenfeld Lamm
Senior Director, Global Quality and Reg CMC Policy, Merck & Co., Inc., United States
Panelist
Roberto Conocchia, MSC
GMP technical Lead, European Medicine Agency (EMA), Netherlands
Manufacturing Closer to the Patient
Marcel Hoefnagel, DRSC, PHD, MSC
Senior Assessor Biopharmaceuticals, Medicines Evaluation Board , Netherlands
EU Perspective on Enabling Innovation in Manufacturing
Sau Lee, PHD
Deputy Super Office Director, OPQ, CDER, FDA, United States
FDA Perspective on Enabling Innovation in Manufacturing
Gert Thurau, PHD
Head of CMC Regulatory Policy for Manufacturing Technology Innovation in , F. Hoffmann-La Roche Ltd, Switzerland
Artificial Intelligence/Machine Learning in Pharmaceutical Manufacturing: The Opportunity for a Low-Risk Deployment of AI
Benjamin Stevens, PHD, MPH
Senior Director, Regulatory Affairs CMC Policy and Advocacy, Alnylam Pharmaceuticals, Inc., United States
Panelist
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