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Hotel Ilunion Alcora Sevilla

Sep 27, 2022 8:30 AM - Sep 28, 2022 3:00 PM

San Juan de Aznalfarache, 41920 Sevilla, Spain

Accelerating CMC Workshop

This Workshop will focus on the currently most relevant topics in the CMC (Chemistry, Manufacturing and Controls) regulatory space with a global perspective.

Session 7: Quality Innovation

Session Chair(s)

Ben  Thompson

Ben Thompson

Vice President, CMC and Non-clinical Regulatory Affairs

GlaxoSmithKline, United Kingdom

Sylvie  Meillerais, MSc

Sylvie Meillerais, MSc

Director Global CMC Policy

MSD Belgium, Belgium

Veronika  Jekerle, PhD, RPh

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.


Veronika  Jekerle, PhD, RPh

EMA Quality Innovation Group & ITF

Veronika Jekerle, PhD, RPh

European Medicines Agency, Netherlands

Head of Pharmaceutical Quality

Joel  Welch, PhD

Where is ETT at across modalities?

Joel Welch, PhD

FDA, United States

Associate Director for Science and Biosimilar Strategy, OBP, OPQ, CDER

Dirk  Leutner, PhD

EDQM’s Experience

Dirk Leutner, PhD

EDQM/Council of Europe, France

Llorente  Bonaga, PhD

Example of CM Process: flow-based co-precipitation amorphous dispersion - cPAD

Llorente Bonaga, PhD

Merck & Co. USA, United States

Director, Regulatory Affairs, CMC

Christian  Wetter, PhD

Opportunities of a mini-batch direct compression technology for accelerated drug product development and manufacture

Christian Wetter, PhD

Roche, Switzerland

Technical Regulatory Advisor

Nélio Cézar  de Aquino, MSc

Panel discussion with Q&A

Nélio Cézar de Aquino, MSc

ANVISA, Brazil

General Manager of Medicines

Saeed  Al Awadh

Panel discussion with Q&A

Saeed Al Awadh

Saudi Food and Drug Authority, Saudi Arabia


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