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Session 5: ICH Topics under Development Part 1
Session Chair(s)
Ursula Busse, PhD, MBA
Head of Regulatory Affairs
Tigen Pharma SA, Switzerland
Sylvie Meillerais, MSc
Director Global CMC Policy
MSD Belgium, Belgium
This session will explore current and future ICH hot topics in the CMC/quality space. Through joint regulators/industry presentations, participants will learn about the most recent developments for ICH Q12, Q13 and Q14/Q2 and gain insights into the new concepts, their practical application and next steps. We will hear from leaders of the recently formed ICH Quality Discussion Group about current plans and future recommendations for ICH quality guidelines. Presentations will be followed by interactive discussions with industry and regulatory members of the different Expert Working Groups.
Speaker(s)
Q12 – Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management: Post-ICH Meeting Update
Frank Montgomery, PhD
AstraZeneca, United Kingdom
Global Head Regulatory CMC, GRAPSQA
Q13 - Continuous Manufacturing: Industry Expectations, Experience and Case Studies
Marta Antunes, MPharm, RPh
MSD, United Kingdom
Sr. Specialist, Regulatory Affairs, International CMC, EU/EEMEA Region
Q13 - Continuous Manufacturing: Industry Expectations, Experience and Case Studies
Meike Vanhooren, DrSc, PhD
Pfizer Inc., Germany
Senior Director
Q14 - Updates on the Guideline
Oliver Grosche
Elanco, Switzerland
Director Collaborative Solutions, R&D Pharmaceutical and Vaccines Sciences and T
Q14 - Updates on the Guideline
Christof Finkler, DrSc
F. Hoffmann-La Roche AG, Switzerland
Senior Technical Advisor Biotech Development
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