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Accelerating CMC Workshop

Innovation and Convergence in a post COVID-19 world


Session 4, Part I: Innovation: Myth or Reality?

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)

Tina  Engraff

The Pharma Strategy - Setting the Scene for Innovation

Tina Engraff

  • Policy officer, DG Health and Food Safety,
  • Unit B5 - Medicines: policy, authorisation and monitoring, , European Commission, Belgium
Laurence  O'Dwyer, RPh

Horizon Scanning and 3D printing case study

Laurence O'Dwyer, RPh

  • Scientific Affairs Manager
  • Health Products Regulatory Authority, Ireland
Sylvie  Meillerais, MSc

Agile Manufacturing: Industry Perspective

Sylvie Meillerais, MSc

  • Director Regulatory Policy
  • Merck Sharp & Dohme LLC, United States
Marianne   Ashford

Future Therapeutics and Regulatory Challenges – Nanomedicines

Marianne Ashford

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

Future Therapeutics and Regulatory Challenges – Oligonucleotides

Christian Wetter, PhD

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

FDA Emerging Technologies Task Force – Examples & Case Study

Joel Welch, PhD

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

EMA’s Role in Facilitating Innovation via the Accelerated Development Toolbox: the experience of the COVID-19 vaccines

Ragini Shivji, PhD, RPh

  • Principal Quality Specialist
  • European Medicines Agency, Netherlands