Very few tasks in early drug development are as challenging as selecting the adequate starting dose and defining appropriate dose escalation schemes in early clinical trials.
About this Workshop
This workshop has been developed by a team of experienced specialists to specifically address non-clinical to clinical translational aspects on the grounds of the recently revised European Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products, which came into effect in February this year.
The workshop will guide you through the following topics:
- Non-clinical basis, including pharmacology, DMPK and Toxicology
- Translational modelling
- And finally the integration of the clinical outcome: reality check and refinement/lessons learned – has it worked?
This workshop will provide an excellent opportunity to foster a broader understanding of translational approaches and stimulate discussions how to implement these in early drug development including experts from regulatory agencies, industry, ethical review committees, academia and investigators.
Workshops at AGAH
Over the last years, AGAH has been organising as series of workshops and discussion forums to address the events in Rennes and to contribute to the revision of the European FIH guideline. This upcoming workshop is in line with the earlier activities and will focus on how to implement translational approaches from a practical perspective for the purpose of designing early clinical trials and of assessing their adequacy and significance.