An update of the EMA guideline on strategies to identify and mitigate risks for first-in-man and early clinical trials came into effect on February 1st, 2018. This update was directly motivated by a serious accident occurring during a first-in-man trial conducted for the pharmaceutical company Bial.
At this PopSim meeting we will have a close look at the trial that has influenced how early clinical trials are conducted today and learn about the implications for the design of these trials. In the second half of the meeting, participants will be applying these principles for designing a first-in-man trial based on available nonclinical data for a hypothetical compound.
Please feel free to forward this invitation to any colleagues with an interest in first-in-man trial design, as the meeting will be relevant also for those without a background in modelling.
14:35 Reason for guideline update: The Bial case (Trine Høyer Rose, Novo Nordisk)
15:00 Implications of the revised EMA guideline for early clinical trials (Mia Lundblad, Ferring Pharmaceuticals)
15:45 Coffee break and networking
- Interactive discussion in small groups: hands-on design of first-in-man trials
- Discussion of pros and cons of proposed trial designs
16:55 Closing remarks
Participation is free of charge. However, if you value PopSim as a place to develop your network and scientific horizon within quantitative pharmacology, please support us by getting a membership (275kr/year) for our organisation within the Danish Pharmaceutical Society. http://farmaceutisk-selskab.dk/en/indmeldelse/
Stine Timmermann Ottesen, Lene Alifrangis and Daniël Jonker