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.
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.