ISPE Expert Xchange: COVID-19 and the Vaccine

Next-Generation Virtual Experience

Complimentary
Learning Level: Intermediate
Session Length: 4 hours


In response to the recent COVID-19 pandemic, the urgency for rapid development, authorization/approval & supply continuity of a new mRNA platform vaccine required an adjustment of conventional development & regulatory approaches. The pharmaceutical industry & regulatory authorities globally, engaged in close & frequent interactions to ensure that a safe & effective vaccine could be globally distributed reliably & administered widely.

This Expert Xchange will feature interactive sessions with our speakers and panelists discussing the COVID Virus itself and the mutations that have developed, as well as development of the COVID-19 mRNA Vaccine and Regulatory Approval

First-hand Strategic Insights & Actionable Takeaways 

  1. The delivery of COVID-19 vaccines would not have been effectively achieved without several paradigm shifts:

    • Parallel rather than sequential product and process development.
    • Collaborative alignment on a balance of flexibility in regulatory agility.
    • Mutual, risk-based reliance among regulatory authorities globally.
Small group Discussions
Small Group Discussions
Technical Presentation
Technical Presentations
Case Studies
Case Studies
Problem-Solving
Problem-Solving

Don’t miss out on this next-generation virtual experience – ISPE Expert Xchange!


Agenda

Thursday 18 November 2021

ISPE Expert Xchange Session Speakers

Anne Stokes, PhD
Director TSE and Virus Control
GlaxoSmithKline
Frank Montgomery, PhD
Global Head, Regulatory CMC
AstraZeneca
Roger Nosal
Head of Global Regulatory Strategy and Submissions
NGT Biopharma
Timothy J.N. Watson, PhD
Vice President – Head of CMC Regulatory Affairs
Gilead Sciences