This workshop looked at how maturing markets are building risk-based approaches into regulatory assessment, building on recent CIRS workshops in Singapore (2019) and South Africa (2018). The workshop also [...]
This workshop builds on the outcomes of the CIRS Professor Breckenridge memorial workshop in December 2020, as well as the 2021 workshop on utilisation of digital technologies in clinical [...]
As regulatory systems mature with demand for new innovative treatments, jurisdictions are seeking to introduce more comprehensive healthcare systems; this is often accompanied by efforts to initiate health technology [...]
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? [...]
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 [...]
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 [...]
Background: Pharmaceutical companies and regulatory agencies endeavor to relate their decision making with outcomes to improve future decision making and to ensure that gained knowledge is fed back into [...]
