---
title: "NGS in Viral Safety: What Do Regulators Really Expect? "
description: In this webinar, learn about a real-world case study implementing iDTECT® NGS-based viral safety testing for a cord tissue–derived MSC master cell bank.
---

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# NGS in Viral Safety:

# What Do Regulators Really Expect? 

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## Presenter:

****![06-18-2026-PathoQuest-ATE-Speaker-HS-Cropped](https://bpi.bioprocessintl.com/hs-fs/hubfs/06-18-2026-PathoQuest-ATE-Speaker-HS-Cropped.png?width=160&height=231&name=06-18-2026-PathoQuest-ATE-Speaker-HS-Cropped.png)**Amina Cherif Louazani, PhD**

*Viral Safety & Regulatory Affairs Manager,*

PathoQuest 

 

Amina Cherif Louazani, PharmD, PhD, has a strong background in virology and bioinformatics. She holds a doctoral degree in infectious diseases from Aix-Marseille University, France, with a specialization in molecular virology and the application of NGS for viral transcriptome analysis. Amina has authored several peer-reviewed articles and held various research and clinical positions. At PathoQuest, she leverages her expertise to conduct expert reviews of viral safety assessments for the NGS-based iDTECT® platform of assays and provides regulatory support for QC strategies and global regulatory filings.

## 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.

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