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Session 7: Quality Innovation
Session Chair(s)
Ben Thompson
Vice President, CMC and Non-clinical Regulatory Affairs, GlaxoSmithKline, United Kingdom
Sylvie Meillerais, MSc
Head of CMC Excellence, Institut De Recherches Internationales Servier, France
Veronika Jekerle, PhD, RPh
Head of Pharmaceutical Quality, European Medicines Agency, Netherlands
This session will explore ways to engage with Regulators on Quality Innovation, with a distinguished panel of experts from Agencies and Industry. EMA will report on progress with establishing its new Quality Innovation Group (QIG) to support the development of increasingly complex manufacturing processes, control strategies, materials, etc. Industry speakers will also provide illustrative examples of innovative solutions, and all will be followed by an interactive panel discussion.
Speaker(s)
Veronika Jekerle, PhD, RPh
Head of Pharmaceutical Quality, European Medicines Agency, Netherlands
EMA Quality Innovation Group & ITF
Joel Welch
Deputy Office Director, OPQA III, OPQ, CDER, US FDA, United States
Where is ETT at across modalities?
Dirk Leutner, PhD
, EDQM/Council of Europe, France
EDQM’s Experience
Llorente Bonaga, PhD
Director, Regulatory Affairs, CMC, Merck & Co. USA, United States
Example of CM Process: flow-based co-precipitation amorphous dispersion - cPAD
Christian Wetter, PhD
Senior Regulatory Portfolio Director, Roche, Switzerland
Opportunities of a mini-batch direct compression technology for accelerated drug product development and manufacture
Nélio Cézar de Aquino, MSc
General Manager of Medicines, ANVISA, Brazil
Panel discussion with Q&A
Saeed Al Awadh
Expert, Saudi Food and Drug Authority, Saudi Arabia
Panel discussion with Q&A
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