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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
Director Global CMC Policy
MSD Belgium, Belgium
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?
Joel Welch, PhD
FDA, United States
Associate Director for Science and Biosimilar Strategy, OBP, 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
Technical Regulatory Advisor
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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