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November 2017

Optimal design and analysis of clinical trials

9. November 2017 @ 14:00 - 18:00
Københavns Universitet, Nørregade 10
København K, 1165 Danmark
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November 9, 2017 at 14:00 – 16:00 Benzon Auditorium, University of Copenhagen Universitetsparken 2, 2100 København Ø Careful planning of the clinical trial design is pertinent in obtaining the best estimation of the dose-response or exposure-response relationships. Thus, issues in trial conduct such as design, dose-selection, sample size allocations and analyses should be thoughtfully addressed during trial design in order to get the best precision of parameter estimates. The current meeting will give an overview on optimal design opportunities and…

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September 2018

PopSim Meeting: Adding confidence to your pharmacometric models

12. September 2018 @ 15:00 - 18:00
Novo Nordisk A/S, Vandtårnsvej 108
Søborg, 2860 Denmark
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Please be invited for a new PopSim meeting on September 12th 2018. This time we have an exciting agenda on uncertainties in nonlinear mixed effects models. Pharmacometric models are gaining increasing impact on decision-making in drug development and clinical therapy. As a consequence the uncertainties involved in model predictions become increasingly important. At this meeting we will discuss the various possibilities and assumptions when calculating and presenting confidence intervals in different settings relevant to clinical drug development. In particular we…

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March 2019

PopSim Meeting: Updated EMA guideline – Background and implications for design of First-In-Man trials

14. March 2019 @ 14:30 - 17:00
Ferring Pharmaceutical A/S, Kay Fiskers Plads 11
Copenhagen, Denmark
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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.…

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