Senior Regulatory Advisor

Mette holds a PhD from University of Copenhagen and provides expert regulatory advice on EU Paediatric Investigation Plans (PIPs) and US Paediatric Study Plans (PSPs).

Mette has a background from both authorities and industry.

• In the Danish Medicines Agency, she was nonclinical assessor of Marketing Authorisation Applications, EU Scientific Advice, and clinical trial applications. She was member of the SWP, Gene Therapy WP, Biosimilar WP, and PGWP, and was rapporteur for CHMP and ICH guidelines.
• As Scientific Officer in EMA, Mette handled PIP procedures with PDCO, advised companies on PIP procedures, was in the FDA-EMA paediatric cluster, and established and ran the PDCO Nonclinical Working Group.
• In Novo Nordisk, Mette had positions as Global Regulatory Lead, Department Manager in Regulatory Affairs, Toxicologist and Principal Scientist. Mette lead all PIP/PSP procedures, was paediatric strategy advisor across the company, and was in the EFPIA paediatric group.

Mette also spent a year as Senior Director and Regulatory Lead in Shionogi, London.