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Professor Olaf Klungel
Professor of Pharmacoepidemiologic Methods,
University of Utrecht
Professor Marie Louise De Bruin
Professor of Drug Regulatory Sciences,
University of Utrecht
Abstract:
Real-world data (RWD) can be used across the drug development life-cycle of medicines. In this seminar we will focus on the use of RWD in non-interventional studies to generate real-world evidence (RWE) for regulatory purposes. We will discuss non-interventional studies with descriptive and causal objectives (in particular the use of estimand and target trial emulation frameworks). Finally, we will share experience from collaboration between academia and regulatory agencies such as the Dutch Medicines Evaluation Board and the European Medicines Agency.
Biographies:
Prof. Olaf Klungel:
Olaf Klungel is Professor of Pharmacoepidemiologic Methods, chair of the division of Pharmacoepidemiology & Clinical Pharmacology, and scientific director of the Utrecht Institute of Pharmaceutical Sciences (UIPS) at Utrecht University. His main research area is the development, improvement and evaluation of innovative methods of observational drug research. Prof. Klungel is member of the Methodology Working Party of the European Medicines Agency, past-elected member of the Steering Committee of ENCePP, past President of the International Society of Pharmacoepidemiology (ICPE) and is PI of the EU Pharmacoepidemiology & Pharmacovigilance Research Network (EU PE&PV). He is Editor of the European Office of Pharmacoepidemiology & Drug Safety.
Prof. Marie Louise De Bruin:
Marie Louise (Marieke) De Bruin, professor in Drug Regulatory Science at Utrecht University, the Netherlands and scientific director of the Utrecht Centre for Pharmaceutical Policy and Regulation. She has combined academic research with advice for health authorities since 2008, both nationally (Pharmacovigilance expert for the Dutch Medicines Evaluation Board 2008-2016, Health Council of The Netherlands 2023-now) and internationally (European Commission appointed independent Scientific Expert of the Pharmacovigilance Risk Assessment Committee (PRAC), at the European Medicines Agency 2012-2018). Working as a regulator has given Prof. De Bruin theoretical training about and hands-on experience in the functioning of the regulatory system. She has wide experience in leading public-private as well as academic research collaborations, nationally, at EU level and globally.
Details
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| Venue: |
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Lecture Theatre 1,
G/F, William MW Mong Block,
21 Sassoon Road, Pokfulam
Hong Kong SAR, China
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