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

Head of Global Regulatory Strategy and Submissions

NGT Biopharma

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.

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

Head of Global Regulatory Strategy and Submissions

NGT Biopharma

Timothy J.N. Watson, PhD

Vice President – Head of CMC Regulatory Affairs

Gilead Sciences

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.