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Paediatric Investigation Plans

<P>This on-demand course focuses on providing an introduction to Paediatric Investigation Plans (PIPs) and the EU Paediatric Regulation.</P>

Facultad

Mette  Due Theilade Thomsen, PhD

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.

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