An efficient regulatory process can be reflected in measurable positive health impacts; conversely, activities that slow or impede regulatory efficiency and predictability can be detrimental. Recent developments in the [...]
Unfortunately, given current circumstances, we have had to postpone our June workshop. Please see below for our revised list of workshops. 15-16 September, Bogota, Columbia Effectiveness of the regulatory [...]
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 [...]
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 [...]
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 [...]
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'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? [...]
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 [...]
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 [...]
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 [...]
