Regulatory Interactions & Conditional Coverage
Regulatory interactions & conditional coverage / Access with evidence development
This Interest Group will focus on the changing dynamics around evidence development that are leading to greater interaction with regulatory stakeholders as well as the increasing interest in mechanisms that involve conditionality of access relating specifically to evidentiary development.
The scope of this Interest Group includes:
- Adaptive pathways
- Early dialogue / scientific advice involving both regulators and HTA bodies
- HTA-Regulatory Interactions relating to evidence development
- Managed entry agreements (focussed on outcomes-based agreements)
- Performance-linked Risk Sharing Agreements (PBRSAs)
- Coverage with evidence development (CED)
- Conditional treatment continuation (CTC)
- Post-marketing additional data collection
This interest group provides a regularly updated repository for the benefit of our members and the wider community. This repository contains a bibliography of peer-reviewed publications relating to HTA-Regulatory Interaction and also Conditional Coverage. In addition, there is a list of governmental and non-governmental initiatives relating to new HTA-Regulatory Interactions, such as emerging parallel scientific advice initiatives.
- Peer reviewed publications
- Governmental and non-governmental activities of interest to the RICC
- HTAi documents and materials of relevance to RICC
News and meetings
RICC is currently preparing abstract submissions for the coming HTAi 2017 Annual Meeting, Rome, Italy.
RICC activities at the HTAi 2016 Annual Meeting, Tokyo, Japan
- Panel on Clinical Uncertainty and Risk Sharing 11:30-13:00 Thursday 12 May, Starlight
- RICC Annual Business Meeting 12:45-14:15, Friday 13 May, Keyaki
The RICC Interest Group was formed in 2016 through the merger of two existing Interest Groups that were found to have increasing overlap in their activities. The two Interest Groups that were merged were the HTA-Regulatory Interaction IG and the Conditional Coverage/Access with Evidence Development IG.
Chair: Dr. Massoud Toussi (France), 2017-2019
Vice Chair: Dr. Michelle Mujoomdar (Canada), 2017-2019
Technical Officer: Lorena Pozzo (Brazil)
Dr. Franz Pichler (Australia)
Prof. Dr. Urs Brgger (Switzerland), Past Chair
Richard Charter (Switzerland), 2017-2019, Past Vice Chair
Join this IG
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