Selecting the adequate starting dose and defining appropriate dose escalation schemes in early clinical trials? A real challenge! Therefore, this workshop has been developed to specifically address translational aspects from the non-clinical to the clinical phase allowing for unique and detailed insight in a highly interactive manner between participants. A team of experienced experts including from industry, CROs, regulatory authorities, ethical review committees and investigators has put together a program which is entirely based on real examples. These case studies will be discussed step-by-step 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.
Each case study will be presented and discussed to guide you through the following topics:
- 1. The non-clinical basis, including Pharmacology, DMPK and Toxicology
- 2. Translational modelling from non-clinical to clinical studies
- 3. 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 is designed for participants from regulatory agencies, industry, ethical review committees, academia and for investigators.
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 these earlier activities. It will focus on how to implement translational approaches from a practical perspective to design early clinical trials and to assess their adequacy and significance.
