讲师团队
Mette Due Theilade Thomsen, PhD
CEO, PIP Adviser, Denmark
Mette is Managing Director of "PIP Adviser" which provides expert regulatory advice on PIPs and PSPs. She has a background in authorities & industry. In the Danish Medicines Agency (2000-2006), she was nonclinical assessor of MAAs and EU Scientific Advice. She was member of the SWP, Gene Therapy WP, Biosimilar WP and PGWP and a rapporteur for CHMP and ICH guidelines. As Scientific Officer in EMA, Mette handled PIP procedures with PDCO, was in the FDA-EMA paediatric cluster and established the PDCO Nonclinical Expert Group. In Novo Nordisk (2009-2017), Mette lead all PIP/PSP procedures, was paediatric strategy advisor across the company and was in the EFPIA paed group. Mette also spent a year as Senior Director in Shionogi, London.