Over 5 years experience (2006-2011) as non-clinical assessor in two regulatory National Competent Authorities (previously at AEMPS in Spain, and currently at MHRA in UK), dealing with the toxicological assessment of extractables and leachables in the applications for marketing authorisation and variations of human medicinal products, among other responsibilities.
Enter your contact details and the nature of your enquiry below:
*Mandatory
Carsten Worsøe is a research scientist in an analytical development department at Novo Nordisk. In his 10 years at Novo Nordisk, his main responsibility has been to develop analytical methods for L&E test procedures of new packaging/container closure systems under development.
Since 2002, Thomas Egert leads the chromatography team for packaging materials characterization at Boehringer Ingelheim. His team's primary responsibilities are on material selection, extractables and leachables qualification as well as on analytical troubleshooting.
Dr. Dennis Jenke is a Baxter Distinguished Scientist in the Technology Resources Division of the Baxter Healthcare Corporation. In this role, he works with a team of analytical chemistry professionals whose primary responsibility includes the development, validation and application of diverse analytical strategies and methods for the discovery, identification and quantification of trace constituents in pharmaceutically relevant solutions and samples.
Dr Laschi has been with Sanofi Pasteur since 1997 in the Quality Control department, responsible at first for an analytical laboratory and then for the implementation and the management of the stability unit. Today, she is in charge of the definition of the stability policy of the company, including extractables and leachables analyses and she's involved with the drafting of manuals and guidance regarding the control of the stability of the vaccines, the cold chain break and the container-content compatibility.