CORS Annual Conference 2018: Impact of drug regulation on health and society – University of Copenhagen

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CORS Annual Conference 2018: Impact of drug regulation on health and society

CORS Annual Conference in 2017.

Copenhagen Centre for Regulatory Science is pleased to announce its 4th Annual Conference. 

As previous years, the conference in 2018 will feature the most important topics within the field of regulatory studies. This year, the Annual CORS Conference is dedicated to the ‘Impact of drug regulation on health and society’. The topic of the conference was chosen, having in mind the recent debates about the role of drug regulations on the approval of medicines and medical devices. One the one hand, if the drug regulations are overly strict, then there is a risk that it can impede innovations and state-of-the-art medical treatments. On the other hand, if the drug regulation shifts towards a more loose approach, then it might endanger the health and well-being of the patients. Thus, the speakers of CORS conference 2018, will touch upon this bone of contention and discuss the impact of innovation on drug regulation from different perspectives (e.g. biosimilars and emerging digital health innovations). Above that, how can this impact be measured and if there are well-developed methodologies, which could help answer this question? Drug regulation – does it really matter? How to improve the impact of risk communication? This year’s conference will give the opportunity to speakers and attendees to reflect on these questions and bring new ideas to the table.

The conference is a unique platform for discussion and debate for a wide range of experts (academia, regulators, industry, and patient representatives). Last year, the conference attendees highly rated the variety of perspectives and points of view from different stakeholders, the international input of the conference, and a unique combination of high-level speakers and attendees. We are committed to preserve the good tradition from the previous years and make this year’s conference again a success.

Keynote speakers

Mette Gørtz, PhD
Associate Professor
Department of Economics at University of Copenhagen

Her research interests are within health economics, labor, and the economics of the family. Mette Gørtz is an applied micro-economist with an extensive experience in using survey and register data.
She is currently the deputy head of Centre for Health Economics and Policy (CHEP) and project manager of a large project on “Behavioural Responses to Health Innovations and the Consequences for Socioeconomic Outcomes”. More information at (link).

David Martin, MD, MPH
Captain, United States Public Health Service
Associate Director for Real World Evidence Analytics, 
Office of Medical Policy, FDA CDER

David Martin is the Associate Director for Real World Evidence Analytics in the Office of Medical Policy at the FDA    Center for Drug Evaluation and Research. He oversees demonstration projects intended to support the agency’s  evaluation of real world evidence, evaluates real world evidence submissions, and contributes to medical policy  development mandated by the 21st Century Cures Act.
Key focus areas include FDA-Catalyst and PCORI pragmatic trials as well as replication of clinical trial results with non-interventional study designs. He is also the principal investigator for the first study to capture patient-provided primary data through a mobile device application, store it in a secure cloud-based repository, and link it to secondary electronic data in Sentinel and PCORnet. As a former Branch Chief, Division Director, and Acting Deputy Office Director in the Center for Biologics Evaluation and Research, Dr. Martin led analyses of spontaneous reports, formalized risk management planning, and helped develop the Sentinel system. He also served on detail as the FDA Liaison to the European Medicines Agency. Before joining the FDA, Dr. Martin practiced flight and occupational medicine in the U.S. Air Force. He earned his undergraduate degree at the Citadel and his M.D. and M.P.H. at the Johns Hopkins University.

Bert G. Leufkens, PhD
Utrecht Institute for Pharmaceutical Sciences (UIPS) and 
WHO Collaborating Centre for Pharmaceutical 
Policy and Regulation

Dr Leufkens obtained his PharmD and PhD degree from Utrecht University. During the mid-80s he worked at Leiden University and was a Fulbright Fellow at the University of Minnesota (US).
In 1997 he was appointed as full professor of Pharmacoepidemiology at Utrecht University. From 2003-2005 he was the Scientific Director of the Utrecht Institute for Pharmaceutical Sciences (UIPS), and during 2006-2007 head of the Depart­ment of Pharmaceutical Sciences of the Faculty of Science in Utrecht. Dr Leufkens is research and policy-wise active at several (inter)national platforms on drug safety, pharmaceutical policy and regulatory science (e.g. past-member EMA Pharmaco­vigilance Working Party 2005-2009, chair of Dutch Medicines Evaluation Board (MEB) 2007-2017, past- member of the EMA CHMP 2009-2015, past-Pre­si­dent of ISPE, since 2008 Scientific Director of the Utrecht WHO Collaborating Centre for Pharmaceutical Policy and Regulation. He is visiting professor at the Faculdade de Farmácia da Universidade de Lisboa and the Copenhagen Centre for Regulatory Science (CORS). He is (co) author of >500 papers in peer reviewed journals, book chapters and research reports.