Next Generation Sequencing (NGS)

Pre-Conference Workshop on 25 June 2024

Objectives

This workshop will address the existing and announced relevant regulations, present the collected comments of the ECA NGS Task Force where applicable and furthermore experts from industry, laboratories and service providers will report on their experiences with NGS.

Programme

Draft Ph.Eur. 2.6.41 – Content and Comments
Dr Sven M. Deutschmann, Roche
Dr Oleg Krut, PEI


Revision (R2) of Guideline ICH Q5A on Viral Safety Evaluation of Biotechnology Products
Dr Astrid Schwantes, PEI


Use of NGS to Identify Relationships in the Legal Context of Food Safety Controls
Coen van der Weijden, Netherlands Food and Consumer Product Safety Authority


GMP-Compliant Analysis of NGS Data for Detection of Contaminants, Identification of Bacterial and Fungal Strains, and Typing
Dr Stefan Emler, Smart Gene


NGS Strategies from Sample to Report for Microbial Identification and Viral Contamination Detection in Pharma
Dr Inanc D. Eserim, Thermo Fisher Scientific


Diversity of S. epidermidis – NGS Implementation in a GMP environment
Daniel Männle, Novartis


The way NGS is Shaping the Future of Food-Borne Outbreak Investigations in the Netherlands
Charlotte Verbart, Netherlands Food and Consumer Product Safety Authority


Bacterial community structure and dominant species in pharmaceutical manufacturing water revealed by high-throughput sequencing
Saori Shikama, Takeda


Case Studies, Data and Experience on NGS
to be announced, Charles River Laboratories

 

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