CIRS RD Briefing 51 – Submission lag time in the emerging markets
Lag Time (the time from which a product has been granted market authorisation in its first market to the time that its application is submitted for review by an [...]
2012 Workshop report – Patient’s role in benefit-risk assessment
The patient's role in the benefit-risk assessment for the submission and review of new medicines 25-26 April 2012, Hampshire, UK This workshop gained a perspective from various stakeholders in [...]
2011 Workshop report – Evolving the regulatory review process
Evolving the regulatory review process: What are the features that enable a transparent, timely, predictable and good quality review? 6-7th December 2011, Kuala Lumpur, Malaysia This workshop was held to [...]
CIRS RD Briefing 51 – New drug approvals in ICH countries 2002-2011
In 2011, the number of New Active Substances (NASs) approved in all the ICH countries increased compared to 2010, and FDA represented the largest number of new medicines approved [...]
2011 Workshop report – Understanding HTA and coverage processes
HTA and coverage decision-making processes: The key to facilitating transparent access to medicines 28-29th September 2011, Surrey, UK This workshop addressed the central question: given the diversity in the [...]
Salek et al 2012 – Scorecards to Assess the Quality of a Regulatory Submission and Its Review
An efficient review depends not only on timely approval but also on ensuring the quality of the process from construction of the dossier to the ultimate regulatory decision. Two [...]
2011 Workshop report – Visualising benefit risk
Visualising benefit risk: The key to developing a framework that informs stakeholder perspective and clarity of decision making 16-17th June 2011, Washington DC, USA In 2010 CIRS held its [...]
2011 Workshop report – Evidentiary requirements in clinical development
Evidentiary requirements in clinical development: Synchronising phase 3 requirements to meet multiple needs 31st March - 1st April 2011, Geneva, Switzerland A drug development programme is by its very [...]
2011 Workshop report – Regional alignment in Asia Pacific
Regional alignment in Asia Pacific: What needs to be in the regulatory science toolkit to enable good regulatory decision making? 26-27th January 2011, Tokyo, Japan Regulatory agencies are rising [...]
2010 Workshop report – New development paradigms to facilitate early access
New development paradigms: Building regulatory confidence for the early release of medicines 11-12th October 2010, Surrey, UK Over the last 5 years CIRS workshops have suggested a number of [...]