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Session 6: ICH Expansion and the Journey towards Harmonisation
Session Chair(s)
Frank Montgomery, PHD
Global Head Regulatory CMC, GRAPSQA, AstraZeneca, United Kingdom
Susanne Ausborn, PHD
Global Head International Regulatory Policy, Roche, Switzerland
The expansion of ICH brings the promise of more rapid access to medicines to a wider population of patients. It does though make the practicalities of harmonisation across a greater diversity of regulators more demanding. This is particularly the case in the CMC area where the detailed technical requirements not only impact the initial approval but ongoing future supply and accessibility for patients. This session will describe the work of the ICH members in the continued journey towards harmonisation, with some insight from newer members and an industry perspective on the continued opportunities to be tackled.
Speaker(s)
Frank Montgomery, PHD
Global Head Regulatory CMC, GRAPSQA, AstraZeneca, United Kingdom
IQ Survey on Control Strategy Acceptance; Opportunity for further harmonisation
Matt Popkin, PHD
Senior Director, CMC Excellence, Global Regulatory Affairs, GSK, United Kingdom
ICH Quality Discussion Group priorities
Wassim Nashabeh, PHD
Vice President, Global Head of Technical Regulatory Policy & International Ops, Genentech, A Member of the Roche Group, United States
Perspectives on progress to harmonisation from the ICH Assembly
Raphael Sanches Pereira
General Manager of the Office for Medicines, ANVISA, Brazil
Reflections from ICH new Observers and Full Members
Abdullah H. AL-Hatareshah, MSC, RPH
Executive Director for Regulatory Affairs , Saudi Food and Drug Authority, Saudi Arabia
Reflections from ICH new Observers and Full Members
Yahya I. Al-Nujaym, MBA
Director for Standards, Saudi Food and Drug Authority, Saudi Arabia
Reflections from ICH new Observers and Full Members
Milton Bonelli, DrMed
ICH Management Committee Member and Scientific Advice Officer, European Medicines Agency, Netherlands
Panel discussion and Q&A, with the additional participation of
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