Innovation for Health - 13 February 2020
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Innovation for Health - Shaping the future of healthcare

Bert Leufkens

Principal Investigator, Utrecht University

Session

14:35 - 15:35
Impact of innovation for regulatory sciences

Bert is professor of Pharmaceutical Policy and Regulatory Science at Utrecht University. He is research and policy-wise active at several (inter)national platforms on innovation, drug safety, pharmaceutical policy and regulatory science (e.g. past-member EMA Pharmaco¬vigilance Working Party 2005-2009, chair of Dutch Medicines Evaluation Board (MEB) 2007-2017, past-member of the EMA CHMP 2009-2015, past-Pre¬si¬dent of ISPE, since 2008 Scientific Director of the Utrecht WHO Collaborating Centre for Pharmaceutical Policy and Regulation. He is affiliate professor at the Faculdade de Farmácia da Universidade de Lisboa and the Copenhagen Centre for Regulatory Science (CORS). Bert is member of the Scientific Leadership Team of Lygature since 2018. He is (co) author of >500 papers in peer reviewed journals, book chapters and research reports.

Abstract

Regulatory Innovation: opportunities for informed impact
An important driver of societal debate and concern is the misalignment between medical needs and innovation. In this context a pivotal question is whether regulatory systems are part of the problem or of the solution. In order to enable an informed, trusted and constructive rethink of the current regulatory system manner, evidence used to evaluate medicines and their impact on regulatory, clinical and societal outcomes is critical. This is the domain of regulatory science. Regulatory science is essential to improve regulatory effectiveness and efficiency and to enable timely access to new innovations. The days that medical innovation was framed as a big jump from the 'lab to practice' are in the past. The critical role of stakeholders including, among many others, patients, HTA bodies, payers and medical communities, is obvious. Regulatory innovation aims to shape opportunities for informed impact.

Marcel Levi
University College London Hospitals
Annemarie Jorritsma
NVP
Rajiv Vaid Basaiawmoit
Aarhus University & Biosymfonix

Claudia Rijcken
pharmi

Inge Huitinga
Netherlands Brain Bank
Wiro Niessen
Erasmus MC, TU Delft & Quantib
Els Beirnaert
Aelin Therapeutics
Joep Muijrers
PureTech Health
Koenraad Wiedhaup
McKinsey & Company
Esther Talboom-Kamp
Saltro Diagnostics
Elise Meijer
Antwerp Management School & Accenture Strategy
Carine van den Brink
Axon Lawyers
Tim Knotnerus
AgomAb Therapeutics
Sjaak Vink
TheSocialMedwork
Hans Schikan
Topsector Life Sciences & Health
Thijn Brummelkamp
Scenic Biotech
Nadine Rouleaux
Maastricht University
Dharminder Chahal
SkylineDx, Van Herk Investsments, Swanbridge

Marianne van der Steen
RegMedXB & Maastricht University

Sponsors & Partners 2020
Host sponsor
Erasmus MC
Host sponsor
Gemeente Rotterdam
Host sponsor
Life Sciences & Health 010
Platinum sponsor
Platinum sponsor
Gold sponsor
Silver sponsor
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Programme Sponsor AI
Award sponsor
AXON Lawyers
Media sponsor
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