Digitisation and digital health technologies are transforming clinical development; companies, regulators and Health Technology Assessment (HTA) agencies are looking to derive actionable insights from the data being generated. This [...]
Over the last five years, regulatory and HTA interactions, as well multi-HTA and multi-regulatory interactions and collaborations, have evolved in thinking and mutual activities both at a product level [...]
As the regulatory landscape changes to meet new challenges, such as increasingly sophisticated medical innovations, fundamental questions are being raised: What is the role of a ‘modern’ regulator today? [...]
Background: This study was built on the previous 2018/2019 assessment where ICH selected the Centre for Innovation in Regulatory Science (CIRS) to collaborate on the development and the conduct [...]
This workshop was part of a series of global development workshops that brought together mature and maturing regulatory agencies. These workshops successively built on one another and evolved from [...]
We're delighted to present our latest Annual Report, which provides a summary of CIRS projects and workshops undertaken in 2020 as well as case studies depicting CIRS’ impact on [...]
This workshop was part of a series of workshops on reliance, which continues to be an important area of focus for CIRS. It builds on the outcomes of a [...]
This workshop was a follow-on from a collaborative forum held in Utrecht in 2018 entitled What new research can enable a joint approach by regulatory and HTA agencies to [...]
We're delighted to present the inaugural CIRS Annual Report, which provides a summary of projects and workshops undertaken in 2019, as well as a historical perspective of CIRS achievements [...]
Background: According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Articles of Association, the regulatory members of ICH are expected to implement [...]
