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Accelerating CMC Workshop

Innovation and Convergence in a post COVID-19 world


Session 4, Part II: Enabling Pharmaceutical Innovation through Dialogue

Session Chair(s)

Sylvie  Meillerais, MSc

Sylvie Meillerais, MSc

  • Director Regulatory Policy
  • Merck Sharp & Dohme LLC, United States
Ben  Thompson

Ben Thompson

  • Vice President, CMC and Non-clinical Regulatory Affairs
  • GlaxoSmithKline, United Kingdom
While the Covid-19 pandemic has created significant challenges on Regulators, industry and patients, it hasn’t stopped the need to deliver new treatments. Thus, there is no better time to promote Innovation, whether in new modalities or manufacturing, to continuously advance swift delivery to patients worldwide. This session will explore latest developments and opportunities to engage with Regulators on suitability of the regulatory frameworks, and prepare for these advancements to become the ‘new normal’ of the future.

Speaker(s)

Marianne   Ashford

Panel discussion with Q&A, with the participation of:

Marianne Ashford

  • Senior Principal Scientist, Advanced Drug Delivery, Pharmaceutical Sciences, R&D
  • AstraZeneca, United Kingdom
Christian  Wetter, PhD

Contributing Panelist

Christian Wetter, PhD

  • Technical Regulatory Advisor
  • Roche, Switzerland
Joel  Welch, PhD

Contributing Panelist

Joel Welch, PhD

  • Associate Director for Science and Biosimilar Strategy, OBP, OPQ, CDER
  • FDA, United States
Ragini  Shivji, PhD, RPh

Contributing Panelist

Ragini Shivji, PhD, RPh

  • Principal Quality Specialist
  • European Medicines Agency, Netherlands
Ibrahim  Algayadh, PhD, MSc, RPh

Contributing Panelist

Ibrahim Algayadh, PhD, MSc, RPh

  • Scientific Evaluation Senior Expert
  • Saudi Food and Drug Authority, Saudi Arabia
Musaad Saleh Al-Ghasham

Contributing Panelist

Musaad Saleh Al-Ghasham

  • Senior Scientific Evaluation Specialist
  • Saudi Food and Drug Authority , Saudi Arabia
Dmitriy  Rozdestvensky, MD, PhD

Contributing Panelist

Dmitriy Rozdestvensky, MD, PhD

  • Head, Division for Coordination of Common Market for Drugs and Medical Devices F
  • Eurasian Economic Commission, Russian Federation
Laurence  O'Dwyer, RPh

Contributing Panelist

Laurence O'Dwyer, RPh

  • Scientific Affairs Manager
  • Health Products Regulatory Authority, Ireland
Raphael  Sanches Pereira

Contributing Panelist

Raphael Sanches Pereira

  • Health and Regulation Expert / Office Manager
  • ANVISA, Brazil