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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
