DIA CMC Workshop

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Session 1: Innovation and New Technologies – Challenges and Opportunities

Session Chair(s)

Peter Richardson, PhD

Head of Quality, Specialised Scientific Disciplines Department

European Medicines Agency, Netherlands

The session will review digitalisation (Pharma 4.0), from development and manufacture to patient use. Enablers and controls needed to define and implement a Holistic Control Strategy, delivery systems and engagement with regulatory authorities on innovation will be presented.

Speaker(s)

Bridging Industry 4.0 and Pharma 4.0 – the Holistic Control Strategy

Christian Woelbeling, MSc

Werum IT Solutions GmbH, Germany

Senior Director, Global Accounts

Digitalisation of Biotech Processes

Patrick Sagmeister, PhD

Exputec GmbH, Austria

Chief Technology Officer

Perspectives of Digitalisation: Continuous Manufacturing to Patient Interface

Gordon Muirhead, PhD

Leicester School of Pharmacy at De Montfort University, United Kingdom

Visiting Professor of Pharmaceutics

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