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 [...]
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 [...]
Refining the benefit-risk framework for the assessment of medicines: Valuing and weighting benefit and risk parameters 17-18th June 2010, Washington DC, USA Determining the benefit-risk balance of a medicine [...]
Review and reimbursement: Aligning the needs and requirements in clinical development 23rd-24th March 2010, Washington DC, USA The current dynamics of bringing new medicines to market are being influenced [...]