Theme event on big data and medicine

08 November 2018

The U.S. Food and Drug Administration, FDA, the European Medicines Agency, EMA, and Novo Nordisk are among the speakers when the Danish Medicines Agency on 20 November 2018 puts focus on Big Data and medicine under the event heading “From Big Data to Real World Evidence”.

Patients and citizens will have quicker access to new medicines, and the drug regulatory authorities will be forced to rethink how medicines are authorised.

These are some of the consequences that the development of Big Data is expected to have in the pharmaceutical area – and the central focus of the event ”From Big Data to Real World Evidence”, hosted by the Danish Medicines Agency on 20 November 2018.

Representatives from the U.S. Food and Drug Administration, FDA, the European Medicines Agency, EMA, and Novo Nordisk will be speaking at the event, as will the Danish Medicines Agency, which is presently chairing a big data task force established by the network of European medicines agencies, HMA.

The future moves in

Drug development has traditionally been a process where the authorisation of medicines was largely took place on the basis of structured data from well-defined clinical trials. When a new medicine is put on the market, its safety is monitored by means of reported adverse reactions, which are assessed and analysed nationally and in the European collaboration. 

New technologies, multiple data sources and new methods imply that it is possible now to develop and carry out medical data analyses that may supplement the traditional data. These data are unstructured raw data from the real world, hence the name Real World Data. They may be composed of existing health registers and in the future also of data from high-quality data bases, electronic patient records and potentially even the health data generated by for example wearables (such as fitness and health apps on smartphones and watches) that register our daily steps and sleep patterns, etc. 

If you would like to participate in the event, please register by sending an email to dkma@dkma.dk by 14 November 2018. Each registered person will receive a registration confirmation. The event is held in English. The event will be live streamed at our English Twitter profile @DKMA_dk

The event will take place at The Danish Medicines Agency, Axel Heides Gade 1, 2300 København S.

Programme:

08.30-09.00: Light breakfast and networking

09.00-09.15: Welcome and introduction 
/ Nikolai Brun, Danish Medicines Agency

09.15-09.45: Real World data – from the perspective of the FDA 
/ David Martin, FDA

09.45-10.15: Real World data – from the perspective of the industry 
/ Robin Evers, Novo Nordisk

10.15-10.40: HMA/EMA Task Force in Europe – challenges, mapping and next steps / Alison Cave, EMA, and Nikolai Brun, Danish Medicines Agency

10.40-11.00: Panel discussion and Q&A

11.00: Thank you for today

 

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