戻る Agenda
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)
IQ Survey on Control Strategy Acceptance; Opportunity for further harmonisation
Frank Montgomery, PhD
AstraZeneca, United Kingdom
Global Head Regulatory CMC, GRAPSQA
ICH Quality Discussion Group priorities
Matt Popkin, PhD
GSK, United Kingdom
Senior Director, CMC Excellence, Global Regulatory Affairs
Perspectives on progress to harmonisation from the ICH Assembly
Wassim Nashabeh, PhD
Genentech, A Member of the Roche Group, United States
Vice President, Global Head of Technical Regulatory Policy & International Ops
Reflections from ICH new Observers and Full Members
Raphael Sanches Pereira
ANVISA, Brazil
General Manager of the Office for Medicines
Reflections from ICH new Observers and Full Members
Abdullah H. AL-Hatareshah, MSc, RPh
Saudi Food and Drug Authority, Saudi Arabia
Executive Director for Regulatory Affairs
Reflections from ICH new Observers and Full Members
Yahya I. Al-Nujaym, MBA
Saudi Food and Drug Authority, Saudi Arabia
Director for Standards
Panel discussion and Q&A, with the additional participation of
Milton Bonelli, DrMed
European Medicines Agency, Netherlands
ICH Management Committee Member and Scientific Advice Officer