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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)
EMA Quality Innovation Group & ITF
Veronika Jekerle, PhD, RPh
European Medicines Agency, Netherlands
Head of Pharmaceutical Quality
Where is ETT at across modalities?
Dr. Joel Welch
US FDA, United States
Deputy Office Director, OPQA III, OPQ, CDER
EDQM’s Experience
Dirk Leutner, PhD
EDQM/Council of Europe, France
Example of CM Process: flow-based co-precipitation amorphous dispersion - cPAD
Llorente Bonaga, PhD
Merck & Co. USA, United States
Director, Regulatory Affairs, CMC
Opportunities of a mini-batch direct compression technology for accelerated drug product development and manufacture
Christian Wetter, PhD
Roche, Switzerland
Senior Regulatory Portfolio Director
Panel discussion with Q&A
Nélio Cézar de Aquino, MSc
ANVISA, Brazil
General Manager of Medicines
Panel discussion with Q&A
Saeed Al Awadh
Saudi Food and Drug Authority, Saudi Arabia
Expert
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