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European Medicines Agency

Nov 05, 2026 8:00 AM - Nov 06, 2026 5:00 PM

Domenico Scarlattilaan 6, 1083 HS Amsterdam, Netherlands

EMA Paediatric Investigation Plans in-person training course

THE ONLY EMA IN-PERSON TRAINING COURSE providing full introduction to Paediatric Investigation Plans (PIPs) and the EU Paediatric Regulation!

Faculty

Florence  BOCHET, PharmD

Florence BOCHET, PharmD

Regional Regulatory Lead Oncology, Servier, France

Florence Bochet is a Doctor of Pharmacy with a Master's degree in Quality Assurance and Control from Faculté de Pharmacie de Châtenay Malabry (Paris XI). She joined Servier in 2004 and has held different position with Worldwide Regulatory Affairs in Servier including Head of Department for Southern Europe and Benelux registrations. Since 2022, she has served as Regional Regulatory Lead in Oncology, overseeing regulatory strategy for major regions including the EU, Australia, Canada, Switzerland, and the UK. Her expertise spans project coordination, regulatory strategy, and the management of European and international registration files.

Roberto  De Lisa, MD

Roberto De Lisa, MD

Scientific Officer, Paediatric Medicines Office, European Medicines Agency, Netherlands

Dr Roberto De Lisa, Clinical Pharmacologist, joined the EMA in 2006. Since then he held various positions in Medical Information and Pharmacovigilance working for the CHMP Pharmacovigilance Working Party (PhVWP) and the Pharmacovigilance Assessment Committee (PRAC). As of 2015 he joined the Paediatric Office working as Paediatric Coordinator with a special interest in paediatric pharmacovigilance. Prior to joining the EMA, Dr De Lisa worked for the University Hospital San Giovanni di Dio in Cagliari for 5 years, conducting clinical trials and participating in the activities of the local Ethic Committee and in the creation of the Pharmacovigilance Centre. He obtained a Master Degree in PharmacoEconomics from the University of Milan in 2005.

Mette  Due Theilade Thomsen, PhD

Mette Due Theilade Thomsen, PhD

CEO, PIP Adviser ApS, 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.

Adrien  Tessier, PharmD, PhD

Adrien Tessier, PharmD, PhD

Clinical Pharmacologist, Servier, France

Adrien Tessier is a Doctor of Pharmacy with a PhD in Pharmacometrics from Université Paris Cité. He joined Servier in 2016 and has held several positions within the Quantitative Pharmacology department, including Head of the Clinical Pharmacometrics team. Since 2024, he has been serving as Associate Director in the Clinical Pharmacology department. During his time at Servier, Adrien has contributed to multiple programs across oncology, rare diseases, and cardiology, spanning from preclinical development to lifecycle management. His experience includes involvement in key regulatory interactions supporting marketing authorization submissions.

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