Focus on Latin America: Building quality submission and review processes and practices - Overcoming challenges and meeting expectations 23-24 January 2014, Lima, Peru This workshop was held to discuss [...]
Implementing an internationally accepted framework for the benefit-risk assessment of medicines: How close are we to this objective? 20-21 June 2013, Washington DC, USA At the annual CIRS Benefit-Risk [...]
In 2013, the overall number of New Active Substances (NASs) approved by EMA, FDA and PMDA was comparable across the three agencies. Nevertheless, despite this similarity, the number of [...]
Objective: To review NASs first launched between 2005‐2010 and to determine their regulatory status as of 31 December 2012 in USA, Europe, Japan, Canada, Switzerland and Australia to identify [...]
As a first step in the implementation of the Asia-Pacific Economic Cooperation (APEC) Best Regulatory Practice Project, the Centre for Innovation in Regulatory Science conducted a gap analysis survey [...]
Patient voice in clinical development: Can patients contribute to the benefit-risk assessment of new medicines? 13-14 March 2013, Surrey, UK The consensus of the April 2012 CIRS Workshop, The [...]
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 [...]
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 [...]
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, [...]
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 [...]