About this event:

Date: June 18, 2026

Time: 11 AM EDT | 8 AM PDT

5 PM CEST

Duration: 30 minutes

The adoption of next-generation sequencing (NGS) for viral safety testing is accelerating and today many biopharma organizations face a critical question: what exactly do regulators expect when NGS is used in place of or alongside traditional methods?

Differences in regional guidelines, evolving expectations, and limited precedent can create uncertainty around validation strategies, data interpretation, and how to present NGS-based assays results in regulatory submissions.

In this presentation, PathoQuest will share an overview of current regulatory expectations for NGS in viral safety across major agencies and provide practical advice on how to position NGS within your overall safety strategy. Drawing on Pathoquest’s experience supporting clients with NGS-based quality control and regulatory interactions, they will share real-life insights on addressing common agency concerns, building robust justifications, and ensuring smoother review processes.

Attendees will gain perspective on how to better anticipate regulatory dialogue and integrate NGS into a comprehensive viral safety and quality control strategy.

Key Takeaways:

• Current regulatory expectations and levels of acceptance for NGS in viral safety.

• Common regulatory questions and how to proactively address them.

• Practical insights from PathoQuest's experience supporting successful agency interactions.