2013 Workshop report – Ensuring quality of review decisions
Regulatory review: How do agencies ensure the quality of the decision? The role of decision frameworks in the review of new medicines: What are the challenges and solutions that [...]
CIRS RD Briefing 52 – New drug approvals in ICH countries 2003-2012
Active Substances (NASs) approved by both the FDA and PMDA represented the largest number of new medicines approved this decade. Regulatory approvals by EMA were lower than the other [...]
2012 Workshop report – Building the benefit-risk toolbox
Building the benefit-risk toolbox: Are there enough common elements across the different methodologies to enable a consensus on a scientifically acceptable framework for making benefit-risk decisions? 20-21 June 2012, [...]
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 [...]
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 [...]