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 [...]
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, [...]
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 [...]
2011 Workshop report – Understanding HTA and coverage processes
HTA and coverage decision-making processes: The key to facilitating transparent access to medicines 28-29th September 2011, Surrey, UK This workshop addressed the central question: given the diversity in the [...]
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 [...]
2011 Workshop report – Regional alignment in Asia Pacific
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 [...]
2010 Workshop report – New development paradigms to facilitate early access
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 [...]
2010 Executive Forum report – Refining the benefit-risk framework for the assessment of medicines
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 [...]