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Session 4, Part II: Enabling Pharmaceutical Innovation through Dialogue
Session Chair(s)
Sylvie Meillerais, MSc
Director Global CMC Policy
MSD Belgium, Belgium
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)
Panel discussion with Q&A, with the participation of:
Marianne Ashford
AstraZeneca, United Kingdom
Senior Principal Scientist, Advanced Drug Delivery, Pharmaceutical Sciences, R&D
Contributing Panelist
Christian Wetter, PhD
Roche, Switzerland
Technical Regulatory Advisor
Contributing Panelist
Joel Welch, PhD
FDA, United States
Associate Director for Science and Biosimilar Strategy, OBP, OPQ, CDER
Contributing Panelist
Ragini Shivji, PhD, RPh
European Medicines Agency, Netherlands
Principal Quality Specialist
Contributing Panelist
Ibrahim Algayadh, PhD, MSc, RPh
Saudi Food and Drug Authority, Saudi Arabia
Scientific Evaluation Senior Expert
Contributing Panelist
Musaad Saleh Al-Ghasham
Saudi Food and Drug Authority , Saudi Arabia
Senior Scientific Evaluation Specialist
Contributing Panelist
Dmitriy Rozdestvensky, MD, PhD
Eurasian Economic Commission, Russian Federation
Head, Division for Coordination of Common Market for Drugs and Medical Devices F
Contributing Panelist
Laurence O'Dwyer, RPh
Health Products Regulatory Authority, Ireland
Scientific Affairs Manager
Contributing Panelist
Raphael Sanches Pereira
ANVISA, Brazil
Quality Assessment of Synthetic Medicines Office Manager
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