End of day meeting on new EU recommendations on complex clinical trials at the Danish Medicines Agency

29 March 2019

The Danish Medicines Agency invites pharmaceutical companies, researchers and other interested parties to an end of day meeting on the new European recommendations on complex clinical trials which aim to support the development of personalised medicine.

The development of personalised medicine requires entirely new types of trials of increased complexity with so-called master protocols and screening platforms. These trials are often termed umbrella, basket or platform trials in which the design is adapted continuously, and the investigational medicinal products and patient groups change during the conduct of the trial. How do these complex clinical trials differ from traditional trials? How can pharmaceutical companies ensure data quality and maintain high patient safety standards in trials with increased complexity? These are some of the topics that will be discussed at a meeting held by the Danish Medicines Agency on 30 April at 15:00. 

The Danish Medicines Agency has led the establishment of the new European recommendations on the conduct of complex clinical trials. The guidelines were published in the beginning of March. To ensure the recommendations will be well implemented in the pharmaceutical companies and the research environments in general, the Danish Medicines Agency will use this meeting to go through the most important points of the new recommendations, including what should be considered a complex clinical trial and what should be considered as separate clinical trials, and what factors to take into account in complex trials in regard to patients, research responsible persons, collaboration partners and the authorities.

The meeting will be held in english.

Sign up for the meeting before 24 April

The end of day meeting is held on 30 April at 15:00 in the Danish Medicines Agency, Axel Heides Gade 1, 2300 Copenhagen S.

To register, please send an e-mail to Agnete Lindequist Debois, agld@dkma.dk, no later than 24 April 2019.

Read more about the new EU recommendations in the news posted on our website: Common European recommendations establish a framework for testing medicines of the future.

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