"Relevant learning-phase studies are valuable in reducing the number of failed marketing authorization applications for new medicinal products and for speeding up pharmaceutical innovation."
Putzeist et al. 2012
"Cost-effectiveness analysis of drug regulatory measures is feasible and should be considered before developing such measures."
Bouvy et al. 2012
"Taking safety issues into account in the approval process does not seem to impact on the time taken to perform the pre-approval clinical programme."
Arnardottir et al. 2011
Multi-stakeholder home for regulatory innovation
The Escher mission is to optimize patient access to medicines and medical technology through regulatory and policy innovation.
Escher gathers, collates and digests scientific evidence, manages multi-stakeholder dialogue and generates robust and objective conclusions. We work with authorities, academic institutions, companies and NGOs in order to facilitate evidence-based solutions. > Read more
Evidence Generation Methods & Requirements
Escher looks at ways in which evidence generation can be improved, medicine development timelines shortened and costs reduced.
Evidence requirements are examined, and also the routes by which new scientific developments are incorporated into regulation. > Read more
Scientific Dialogue & Stakeholder Interaction
Approaches to improving dialogue between all stakeholders are explored within this theme, with a particular focus on interactions between pharmaceutical companies and regulators.
Decision-Making Process & Benefit-Risk Assessment
Escher looks at how benefit-risk assessments for medicines are made in regulatory agencies and HTA bodies, and studies how these assessments affect development strategies in companies.
In addition Escher has developed tools for structured benefit-risk assessment. > Read more
HTA & Evaluating Societal Impact
Escher examines the economic, social and ethical implications of regulatory procedures.
It also considers how development can be optimized, by better aligning European marketing approval applications and HTA/reimbursement application procedures. > Read more