Event Outline
This workshop will evaluate the current state of development of global clinical oncology trials and regulatory perspectives. The workshop is being organised by CDDF in collaboration with AAADV, bringing together trans-Atlantic experience in clinical trials and regulatory perspectives. It will include representatives from industry and academia, regulatory agencies and health technology assessors, as well as patient advocates, to explore these issues.
At this multi-stakeholder workshop, meeting delegates will have the opportunity to discuss the regulatory issues related to innovative and adaptive trial designs and international programs.
The 1.5-day meeting consists of 3 plenary sessions, and will include adequate discussion and networking time.
Learning outcomes / Meeting objective
From this interactive workshop, participants will achieve the following outcomes:
- To understand the options for global harmonization, including the challenges of balancing country enrollment and the use of non-local data for local regulatory approvals.
- To gain insights into the ICH E22 guideline on patient preferences and learn practical strategies for ensuring diversity and inclusion within global clinical trials.
- To evaluate novel trial designs and the critical role of Patient Reported Outcomes (PROs) from a patient perspective to support successful drug development and reimbursement.
- To learn how oncology trials have transitioned from chains of subsequent studies to complex, multi-functional designs, and understand the options for cohort adaptations in early-phase oncology.
- To identify the cornerstones of successful global drug development that enable faster approvals and reimbursement strategies.
Target audience
The target is a multidisciplinary audience of academia representatives, EU and US regulatory bodies (EMA, FDA, National Agencies), the pharmaceutical industry, HTAs, and patient advocates.
Language
The main language of the workshop is English.