Annelies Rombout

Performance Evaluation Studies Manager

Meet Annelies Rombout.

Annelies Rombout (born 1973, Belgian citizen) has a bachelor’s degree in biotechnology. She has already gained more than 23 years of experience in the In Vitro Diagnostics industry and held positions in R&D and clinical development at Fujirebio Europe (formerly Innogenetics N.V.) before joining Qarad in 2017.

At Qarad, Annelies is responsible for the coordination and managing of  performance evaluation studies. Moreover, she has experience in writing analytical and clinical performance study plans and reports, data collection and analysis, and study monitoring from a wide range of IVD products (infectious diseases, HLA-typing, Cystic Fibrosis, Vitamin D, cardiac).

Her goal is to use her built up IVD product development and performance evaluation expertise to assist diagnostic customers in demonstrating clinical evidence for their IVDs.

Annelies started her career at Innogenetics N.V. in 1995 as team member during research and development of nucleic acid-based in vitro diagnostic assays and became project lead for the HLA-typing range assays in 2003. In 2009, she joined the clinical development team as Senior Clinical Developer for Fujirebio Europe. Her major competences are:

  • Product development, qualification, verification and validation of HLA typing assays
  • Analytical and clinical performance activities of nucleic acid and protein-based quantitative or qualitative in vitro diagnostic assays

 

Qarad IVDR Conference 2022

NHOW Brussels

October 11-13

Get the latest IVDR insights during our three-day conference, including a pre-conference workshop.