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Innovation in Manufacturing Globally
Session Chair(s)
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, 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)
Panelist
Celeste Frankenfeld Lamm, PhD
Merck Sharp & Dohme LLC , United States
Senior Director, Global Regulatory Affairs – CMC
Manufacturing Closer to the Patient
Roberto Conocchia, MSc
European Medicine Agency (EMA), Netherlands
GMP technical Lead
EU Perspective on Enabling Innovation in Manufacturing
Marcel Hoefnagel, DrSc, PhD, MSc
Medicines Evaluation Board , Netherlands
Senior Assessor Biopharmaceuticals
FDA Perspective on Enabling Innovation in Manufacturing
Sau L Lee, PhD
FDA, United States
Deputy Super Office Director, OPQ, CDER
Artificial Intelligence/Machine Learning in Pharmaceutical Manufacturing: The Opportunity for a Low-Risk Deployment of AI
Gert Thurau, DrSc, PhD
F. Hoffmann-La Roche Ltd, Switzerland
Head of Manufacturing Technology Innovation in CMC Regulatory Policy
Panelist
Benjamin Stevens, PhD, MPH
GlaxoSmithKline, United States
Director CMC Policy and Advocacy
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