Faculty
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.
Andrea Ecker
Scientific Officer, Paediatric Medicines Office, European Medicines Agency, Netherlands
2008-2011 Postdoctoral researcher Department of Microbiology, Columbia University Medical School, New York (USA). 2011-2013 Trainee and then Scientific Administrator in the Anti-Infectives Office, European Medicines Agency. Since 2013 Scientific Officer in the Paediatric Medicines Office, European Medicines Agency. Responsible for assessment of PIP applications, modifications, waivers and compliance checks with PDCO, and for paediatric validations of marketing authorisations and other relevant regulatory submissions.
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