CIRS RD Briefing 75 – Emergency Use Pathways (EUPs)
It has become clear that agencies have a number of pathways that can be used during public health emergencies for the authorisation of therapeutics and vaccines. Some of these [...]
CIRS selected as Technical Partner for PQM+ programme
We’re delighted to announce that we’ve been selected as a Technical Resource Partner for the Promoting the Quality of Medicines Plus (PQM+) programme, which is funded by the US Agency [...]
Revised list of CIRS workshops
Unfortunately, given current circumstances, we have had to postpone our March workshop. Please see below for our revised list of workshops. 11-12 June, Tyson's Corner, USA Digital health: exploring the [...]
CIRS Awarded a Grant to Help Accelerate Registration of Medicines in Low and Middle Income Countries
We’re delighted that the Bill and Melinda Gates Foundation is continuing to support our work with medicine regulatory agencies in low- and middle-income countries (LMICs) through the OpERA programme. The [...]
December 2019 Slide of the Month
December's Slide of the Month is taken from a CIRS poster recently presented at ISPOR Europe 2019. Does FDA Breakthrough Designation affect HTA recommendation in terms of timing and outcome? [...]
Project report – Monitoring implementation and adherence to ICH guidelines
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 [...]
Executive Colloquium report – What is the value and return on investment for our company to maintain a regulatory policy function?
In June 2019, the Centre for Innovation in Regulatory Science (CIRS) held an Executive Colloquium in Rockville, MD, USA that brought together representatives from multinational pharmaceutical companies to gauge [...]
McAuslane et al 2019 – Confluence of Accelerated Regulatory and HTA Access Pathways
There is a growing interest in aligning accelerated regulatory pathways with flexible access and reimbursement pathways to expedite the equitable availability of high-quality, safe, and effective medicines that provide [...]
Keyter et al 2019 – South African Medicines Control Council: Comparison of Its Registration Process
Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight areas for improvement as authorities move [...]
Bujar et al 2019 – Reliability and relevance of a decision-making instrument
Introduction: The Quality of Decision-Making Orientation Scheme (QoDoS) was developed to provide organisations involved in submission, approval and reimbursement of new medicines with a tool to improve the quality [...]