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March 2019

Market Access – A Changing Landscape for Pharmaceuticals

5. March @ 14:30 - 16:45
Benzon Auditorium, Universitetsparken 2
København Ø, 2100 Denmark
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The conditions for obtaining patient’s access to new medicinal products have changed dramatically during recent years along with expanding pressure on healthcare budgets. What used to be fairly uncomplicated marketing activities after regulatory approval, has transformed into a discipline requiring crucial negotiations between sponsors and payers based on technology assessments. To support such negotiations, focus is not only on clinical development programs to demonstrate efficacy and safety but also on health economic analysis based on real-world evidence of treatment outcome.…

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

14. March @ 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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