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Novel Manufacturing Approaches for Early Access and Sustained Supply
Session Chair(s)
Ursula Busse, PhD, MBA
Head of Regulatory Affairs
Tigen Pharma SA, Switzerland
Nick Lee, PhD
Executive Pharmaceutical Assessor
Health Products Regulatory Authority (HPRA), Ireland
Continuous manufacturing (CM) is used to manufacture, produce, or process materials without interruption. There are several advantages of CM, such as being an integrated processing with fewer steps, no manual handling, shorter processing times, and increased efficiency. More flexible operations use smaller equipment and facilities. Online monitoring and controls result in increased and consistent product quality. CM also speeds up development timelines since no scale up is required.This session will focus on CM as a means to accelerate development programs in a globalized context and support the development of personalized medicines. Participants will gain insights into state of the art CM and get the latest on the proposed ICH regulatory framework (ICH Q13) both from an industry as well as a regulatory perspective. A panel will then address how regulatory frameworks need to evolve to facilitate innovation while guaranteeing patient access to safe and effective medicines. Ample time will be allowed for interactive Q&A.
Speaker(s)
Continuous Manufacturing & Accelerated Development - A Case Study
Meike Vanhooren, DrSc, PhD
Pfizer Inc., Germany
Senior Director
ICH Q13 Continuous Manufacturing: An Industry Perspective
Wendy Zwolenski-Lambert, MSc
Novartis Pharma AG, Switzerland
Director, Regulatory Affairs CMC Strategy and Policy
ICH Q13 and Continuous Manufacturing – Where are we?
Dolores Hernan Perez de la Ossa, PhD
European Medicines Agency, Netherlands
Quality Specialist - Pharmaceutical Quality Office
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