AGAH Workshop beim German Pharm Tox Summit 2018
Pharm Tox Summit 2018, Göttingen
First-in-human trials – what you need to know.
28.2.2018 in Göttingen
Introduction
This workshop addresses young scientists working in basic pharmacological research and other colleagues involved in biomedical research who would like to know more about early phase clinical development. First-in-human trials will be the focus of this workshop. Non-clinical prerequisites, ethical and regulatory requirements, starting dose, dose escalation rules and stopping criteria, design aspects and clinical conduct, as well as pros and cons of integrated protocols will be addressed.
Discuss state-of-the art features of FIH trials with non-clinical and clinical experts. Breaks present a good opportunity to network with faculty and colleagues. The number of participants is limited to 50 persons. Participation fee is 40 Euro for delegates fully registered for the GPTS and 75 Euro for a day ticket for the AGAH Workshop only.
Chairs: Georg Wensing, Wuppertal; Kerstin Breithaupt-Grögler, Frankfurt
| 09:00 | Welcome and Introduction Georg Wensing, Wuppertal |
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| 09:05 – 09:30 | What is a first-in-human trial and what is so special about it? Jens Rengelshausen, Aachen |
| 09:30 – 10:00 | Setting the stage: The revised EMA Guideline on early phase clinical trials Kerstin Breithaupt-Grögler, Frankfurt |
| 10:00 – 10:45 | Which answers do we need from non-clinical pharmacology and toxicology prior to the first human exposure? Stephanie Plassmann, Basel |
| 10:45 – 11:45 | Break for plenary lecture GPTS |
| 11:45 – 12:15 | Networking lunch break |
Chairs: Jens Rengelshausen, Aachen; Barbara Schug, Oberursel
| 12:15 – 13:00 | How to derive the human starting dose? Stephanie Plassmann, Basel |
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| 13:00 – 13:45 | Integrated protocols: The art of combining several questions into one well-designed trial Christian Friedrich, Wuppertal |
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| 13:45 – 14:30 | Clinical conduct of a first-in-human trial Wolfgang Timmer, München |
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| 14:30 – 14:45 | Break | ||||||||||||||||||||||||||||||||
| 14:45 – 15:30 | Challenges in the ethical approval of FIH trials Ignaz Wessler, Mainz |
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| 15:30 – 16:15 | Dose escalation and stopping rules in single and multiple ascending dose parts of a FIH trial Frank Donath, Erfurt |
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| 16:15 – 17:00 | Wrap-up and case study ‘First-in-human trials in healthy volunteers – a ten years review‘ Georg Wensing, Wuppertal |
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| 17:00 | End of Workshop
Chairs: Jens Rengelshausen, Aachen; Barbara Schug, Oberursel
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English
28. February 2018
AGAH Workshop beim German Pharm Tox Summit 2018
Pharm Tox Summit 2018
Göttingen
Deutschland