Event Outline
This workshop will evaluate the current state of play in terms of trials and regulatory perspectives to improve access to innovative therapies in patients with rare cancers. The workshop is being jointly organised by CDDF and EORTC, bringing together their respective expertise in the treatment, clinical trials and regulatory perspectives, and will include representatives from industry and academia as well as patient groups to explore these issues.
At this multi-stakeholder workshop, meeting delegates will have the opportunity to discuss the regulatory landscape for orphan drug indications, innovative trial designs and international programmes to help identify patients for trials and share data to build cohorts.
The 1.5-day meeting consists of 3 plenary sessions and adequate discussion and networking time. Each session will also include various perspectives of academics, HTAs, regulatory agencies, patient advocates and industry and discuss challenges of improving treatment for patients with rare cancers.
Learning outcomes / Meeting objective
From this interactive workshop, participants will achieve the following outcomes:
- To understand the current landscape of patient identification and profiling in rare cancers
- To explore regulatory aspects, challenges and plans for formal registration of novel agents in rare indications
- To learn about the innovative trial designs available and international efforts to improve data collection and outcomes for these patients
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.