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Editorial: Our national approach to regulatory science


Written byRandi Munch Krogsgaard

On 23 November 2016 we celebrate Marie Louise (Marieke) De Bruin as the Professor at The Copenhagen Centre for Regulatory Science (CORS). Following, on 24 November 2016, the University of Copenhagen hosts the Annual Conference of CORS. At this conference current and future initiatives on regulatory science within industry, academia and health authorities worldwide will be outlined. Industry, the patients and the EU EMA, US FDA and Japanese PMDA will give presentations including research areas within regulatory science of medical products. This will be followed by panel discussions and networking.

CORS was established in 2015 in order to develop and support regulatory science as a research and education discipline on a national basis. This was as result of the regulatory science initiative launched by the FDA in the USA in 2010, which increased the attention to regulatory science in the pharmaceutical communities internationally.

Biopeople is part of the partnership behind CORS along with the Danish Medicines Agency, Novo Nordisk A/S, LEO Pharma A/S, H. Lundbeck A/S and Ferring Pharmaceuticals A/S.

The discipline of regulatory science is to develop new tools, standards and approaches to evaluate efficacy, safety, quality and effect of medical products. This is done to assess risk-benefit and facilitate a sound and transparent regulatory decision making and it strengthens the scientific approach in testing and assessing advanced novel therapeutic principles. Ultimately, the regulatory science discipline helps industry to a faster development of new drugs.

In Europe, the Innovative Medicines Initiative (IMI), is a powerful vehicle for regulatory science. IMI brings various public-private stakeholders to table to develop new tools, standards and approaches to medicines development.

Biopeople is involved in the educational pillar of the IMI and activities that build competencies to improve decision-making. As part of that Biopeople co-organizes a training course for the next generation of safety scientists 23-27 January 2017 in Lisbon. Biopeople is also engaged in the establishment of the Danish platform for patient training and engagement in medicines R&D (EUPATI DK,

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