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Accelerating CMC Workshop

Innovation and Convergence in a post COVID-19 world


Session 6: ICH Expansion and the Journey towards Harmonisation

Session Chair(s)

Frank  Montgomery, PhD

Frank Montgomery, PhD

  • Global Head Regulatory CMC, GRAPSQA
  • AstraZeneca, United Kingdom
Susanne  Ausborn, PhD

Susanne Ausborn, PhD

  • Global Head International Regulatory Policy
  • F. Hoffmann-La Roche Ltd., 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

IQ Survey on Control Strategy Acceptance; Opportunity for further harmonisation

Frank Montgomery, PhD

  • Global Head Regulatory CMC, GRAPSQA
  • AstraZeneca, United Kingdom
Matt  Popkin, PhD

ICH Quality Discussion Group priorities

Matt Popkin, PhD

  • Director, CMC Strategy
  • GlaxoSmithKline, United Kingdom
Wassim  Nashabeh, DrSc

Perspectives on progress to harmonisation from the ICH Assembly

Wassim Nashabeh, DrSc

  • VP, Regulatory Policy & International Operations
  • Genentech, United States
Raphael  Sanches Pereira

Reflections from ICH new Observers and Full Members

Raphael Sanches Pereira

  • Health and Regulation Expert / Office Manager
  • ANVISA, Brazil
Abdullah H. AL-Hatareshah, MSc, RPh

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
Yahya I. Al-Nujaym, MBA

Reflections from ICH new Observers and Full Members

Yahya I. Al-Nujaym, MBA

  • Director for Standards
  • Saudi Food and Drug Authority, Saudi Arabia
Milton  Bonelli, DrMed

Panel discussion and Q&A, with the additional participation of

Milton Bonelli, DrMed

  • ICH Management Committee Member and Scientific Advice Officer
  • European Medicines Agency, Netherlands