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Session 6: ICH Topics under Development Part 2
Session Chair(s)
Sylvie Meillerais, MSc
Director Global CMC Policy
MSD Belgium, Belgium
Ursula Busse, PhD, MBA
Head of Regulatory Affairs
Tigen Pharma SA, Switzerland
Session 6: ICH Topics in Development Part 2
Speaker(s)
ICH Survey on Guidelines Implementation
Giovanna Rizzetto
EFPIA, Belgium
Senior Manager, Regulatory, Drug development and Manufacturing
Guidelines Implementation: Lessons Learned from Tier 1 ICH Guideline Training (Q7) and Best Practices for Future Implementation (e.g. Q12)
Frank Montgomery, PhD
AstraZeneca, United Kingdom
Global Head Regulatory CMC, GRAPSQA
Updates from the ICH Quality Discussion Group
Matt Popkin, PhD
GSK, United Kingdom
Senior Director, CMC Excellence, Global Regulatory Affairs
Implementation Q&A and Panel Discussion, with the additional participation of
Hélène Bruguera
European Directorate for the Quality of Medicines and Healthcare (EDQM), France
Head, Certification of Substances Department,
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