Fast Path – From Lab to the Patient. Regulatory Pathways to Facilitate the Implementation of Novel Manufacturing Technologies
June 23, 2026
23BC
Type: Breakout Session
Focus Area:
Biomanufacturing
Novel manufacturing technologies can help rapidly scale manufacturing capabilities, increase supply chain resilience, bring manufacturing closer to the patient, and support greener manufacturing. On a global scale, regulators are actively supporting the adoption of advanced manufacturing technologies through early engagement channels.
This session will present regulatory perspectives on efforts to implement innovation in medicines development, manufacturing and control, and the latest initiatives at ICH and ICMRA level. Industry representatives will share case studies and best practices and discuss how the interactions with regulators have supported their implementation journey. The discussion will focus on the opportunities offered, the remaining challenges, and the priority areas for industry and regulators to work collaboratively to promote and facilitate the implementation of novel manufacturing technologies globally.
Subtopic
Advanced/Innovative Manufacturing Technologies
Moderator
Head of Quality and Safety Dpt; Human Medicines Division, EMA
European Medicines Agency (EMA)
Speakers
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Acting Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research (CDER)
US Food & Drug Administration (FDA)
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