Access to Real-World Data: Unique Opportunities
The webinar is the fourth episode out of a four part webinar series on personalized medicine – from fundamental research to post-marketing activities. Each episode will provide an overview of the Danish research infrastructure within a specific phase of the drug development process and an opportunity for virtual meetings with leading Danish researchers and physicians as well as key officials from public health data organizations, including biobanks, health data, clinical and technology research.
Webinar programme
- Presentation of The Danish Health Data Authority and the national health data landscape by Lisbeth Nielsen, Director General.
- Introduction to The Danish Health Data Authority and overview of the data available in national health data registries.
- Services that The Danish Health Data Authority provide for researchers (both private and public).
- Examples illustrating the use and potential of the national registries when developing and/or using personalized medicine.
- Presentation of the Danish Clinical Quality Program - National Clinical Registries by Jens Winther Jensen, CEO and Medical Director.
- Introduction to the Danish Clinical Quality Program - National Clinical Registries and overview of the clinical data available.
- Services and opportunities for collaboration that RKKP offers industry partners.
- Examples illustrating the use and potential of the national registries when developing and/or using personalized medicine.
- Interview with Vera Ehrenstein, Professor at Department of Clinical Epidemiology, Aarhus University Hospital (public researcher) and Arun Micheelsen, Chief Researcher and Advisor at DLI MI (private researcher) on how to use Danish Registry Data and on how to collaborate with the Danish Health Data Authority and Danish Clinical Quality Program - National Clinical Registries.
Speaker info
Lisbeth Nielsen
Lisbeth Nielsen’s background is grounded in both the public and the private sector. In her current role as Director General at the Danish Health Data Authority, she works to create coherent and systematic health data solutions to benefit patients and practitioners as well as supporting general research and administrative tasks in the Danish health care sector. Before that, Lisbeth Nielsen worked as a Chief Quality Officer at North Zealand Hospital, as Assistant Director at Danish regions and as head of Health Care Sales at IBM. She holds a Master of Public Administration from the University of Roskilde.
Jens Winther Jensen
Jens Winther Jensen is CEO and Medical Director of RKKP - Danish Clinical Quality Program and National Clinical Registries. He works to ensure a continued improvement in the utilization of the Danish clinical registries in a clinical as well as managerial-, and research oriented sense. He holds a MSc degree in medicine, Medical Specialist degree in Anesthesiology, Pain and Intensive Care Medicine and Master of Public Health in Clinical Effectiveness from Harvard University. Jens Winther has had several top management positions in Danish hospitals sector.
Vera Ehrenstein
Vera Ehrenstein is a professor at the Department of Clinical Epidemiology, Aarhus University, Denmark. She has 20 years’ experience conducting epidemiologic studies using Danish registries and other sources of routinely collected data.
Vera is the scientific coordinator on several completed and ongoing multinational regulator-imposed or regulator-commissioned post-authorization safety studies in areas of oncology; cardiovascular disease; skeletal diseases; and safety of medication during pregnancy. She is a member of the Board of Directors of the International Society for Pharmacoepidemiology (ISPE) and a past member of the Steering Group of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). As a member of several ENCePP working groups, she contributes to development of standards and guidances for design and conduct of post-authorization safety studies. Vera has co-authored more than 130 peer-reviewed publications and supervises several PhD and research year students. She is an Associate Editor-in-Chief of an online peer-reviewed periodical Clinical Epidemiology.
Arun Micheelsen
Arun Micheelsen holds a PhD in sociology from Copenhagen University and is employed at the DLI MI in Denmark as Chief Researcher and Advisor.
Beside publishing white papers about Real World Evidence (RWE) and Patient Preference Evidence, Arun supports pharma companies and public researchers with designing RWE studies, applying for health data, accessing and analyzing data, and reporting RWE studies conducted in the Nordic region. These studies often focus on mapping patient populations, treatment pathways, outcome studies, and studies relevant for Market Access – most often employing public health, (pharma-)epidemiological, health economic, and lately also Data Science methods.
Moderator: Allan Skaarup Kristensen
Moderator: Allan Skaarup Kristensen
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