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September 20, 2024 (Friday), 9:00 am – 4:30 pm
Venue: University of Warsaw, Faculty of Applied Linguistics, Dobra 55, Warsaw, Poland.
Save the date and join us in the beautiful city of Warsaw this September. Bringing together expert practitioners from the Phase I community, the workshop will focus on how our collective insights can be utilized to make the Investigator’s Brochure truly fit for purpose.
The primary objective of this workshop is to enhance the Investigator’s Brochure (IB) process, ensuring it serves its true purpose in Phase 1 trials: enabling responsible investigators to conduct reliable benefit-risk assessments. Currently, as raised during our EUFEMED Conference in Berlin in May 2023, practices often reduce the IB to merely a Clinical Trial Authorization document, overlooking the Principal Investigators’ need for a thorough understanding of translational study results to effectively implement necessary risk mitigation steps
In this workshop, we aim to:
- Create a more meaningful IB process focused on translational results interpretation.
- Ensure investigator-centered presentation and decision-making.
- Align with existing and upcoming international requirements
Join us to contribute to our discussions and help shape the future of early-phase trials.
Agnieszka Kulesza
Member of the Board EUFEMED
President POLFEMED
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