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Session 4, Part I: Innovation: Myth or Reality?
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)
The Pharma Strategy - Setting the Scene for Innovation
Tina Engraff
Unit B5 - Medicines: policy, authorisation and monitoring, , European Commission, Belgium
Policy officer, DG Health and Food Safety,
Horizon Scanning and 3D printing case study
Laurence O'Dwyer, RPh
Health Products Regulatory Authority, Ireland
Scientific Affairs Manager
Agile Manufacturing: Industry Perspective
Sylvie Meillerais, MSc
MSD Belgium, Belgium
Director Global CMC Policy
Future Therapeutics and Regulatory Challenges – Nanomedicines
Marianne Ashford
AstraZeneca, United Kingdom
Senior Principal Scientist, Advanced Drug Delivery, Pharmaceutical Sciences, R&D
Future Therapeutics and Regulatory Challenges – Oligonucleotides
Christian Wetter, PhD
Roche, Switzerland
Technical Regulatory Advisor
FDA Emerging Technologies Task Force – Examples & Case Study
Joel Welch, PhD
FDA, United States
Associate Director for Science and Biosimilar Strategy, OBP, OPQ, CDER
EMA’s Role in Facilitating Innovation via the Accelerated Development Toolbox: the experience of the COVID-19 vaccines
Ragini Shivji, PhD, RPh
European Medicines Agency, Netherlands
Principal Quality Specialist
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