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 [...]
Introduction: European countries are increasingly utilising health technology assessment (HTA) to inform reimbursement decision-making. However, the current European HTA environment is very diverse, and projects are already underway to [...]
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 [...]
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 [...]
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 [...]
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 [...]