2024 is a key year for globally considering NGS implementation with the recent publication of the revised ICHQ5A(R2) guideline and the upcoming draft chapter on NGS from the EDQM/European Pharmacopoeia.
The 4th NGS meeting will continue to highlight current scientific data and knowledge with focus on NGS implementation for adventitious virus detection in biological products. Discussions will include capabilities of NGS for virus detection in different matrices and validation of the technical and bioinformatics steps involved in NGS for its applications in characterization and safety evaluation of biologics such as vaccines for human and veterinary use, gene and cell therapy products, and biotherapeutics.
The meeting will bring together representatives from industry, academia, technology providers, and international regulatory bodies for discussing the current applications of NGS as an alternative method for replacing or supplementing the current conventional assays for detection of adventitious viruses in biologics.
A one-day NGS training workshop (December 3rd) to be associated to this conference (December 4th & 5th) is in preparation and further details will be communicated soon.
Scientific Committee
Arifa S. Khan - Co-chair, FDA-CBER (FDA), U.S.A.
Laurent Mallet - Co-chair, EDQM, France
Pieter Neels - IABS Chair, Belgium
Johannes Blümel - PEI, Germany
Noémie Deneyer - GSK, Belgium
Sigrid De Keersmaecker - Sciensano, Belgium
Blandine De Saint-Vis - Boehringer- Ingelheim, France
Ivana Knezevic - WHO, Switzerland
Carine Logvinoff - Sanofi Pasteur, France
Marie Murphy - Eli Lilly, Ireland
Siemon Ng - Notch Therapeutics, Canada
Yoji Sato - National Institute of Health Sciences – Japan