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
  • Virus and the Variants
    Anne Stokes, PhD
    Director TSE and Virus Control
    GlaxoSmithKline
  • Development of the COVID-19 mRNA Vaccine:  Is the Paradigm Shift Sustainable?

    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. 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.

    Despite several statutory and regulatory challenges, the expeditious development, flexible regulatory authorization/approval & rapid expansion of manufacturing capacity demonstrated a collaborative and concerted execution of effort. However, is this approach sustainable beyond the pandemic?

    Roger Nosal, PhD
    Vice President & Head of Global Chemistry, Manufacturing & Controls
    Pfizer Inc.
  • ISPE Networking Coffee Talk

    This face-to-face forum gives you the chance to have 1:1 conversations in small groups via video chat. Connect with attendees and engage with the speakers about their topics during this networking break.

  • COVID Treatments, Vaccine Development and Regulatory Approval with rapid need to get drugs to market
    Frank Montgomery, PhD
    Global Head, Regulatory CMC
    AstraZeneca
  • Panel Discussion on Lessons

    What have we learned from COVID regarding supply chain, future pandemic planning, etc.

    Anne Stokes, PhD
    Director TSE and Virus Control
    GlaxoSmithKline
    Frank Montgomery, PhD
    Global Head, Regulatory CMC
    AstraZeneca
    Roger Nosal, PhD
    Vice President & Head of Global Chemistry, Manufacturing & Controls
    Pfizer Inc.
    Timothy J.N. Watson, PhD
    Executive Director & Team Leader, CMC Advisory Office
    Pfizer Inc
  • ISPE Networking Coffee Talk

    This face-to-face forum gives you the chance to have 1:1 conversations in small groups via video chat. Connect with attendees and engage with the speakers about their topics during this networking break.


ISPE Expert Xchange Session Speakers

Anne Stokes, PhD
Director TSE and Virus Control
GlaxoSmithKline
Frank Montgomery, PhD
Global Head, Regulatory CMC
AstraZeneca
Roger Nosal, PhD
Vice President & Head of Global Chemistry, Manufacturing & Controls
Pfizer Inc.
Timothy J.N. Watson, PhD
Executive Director & Team Leader, CMC Advisory Office
Pfizer Inc

Register


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