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Completed projects
In 2006, the FES-funded (Dutch natural gas reserve fund) research portfolio triggered the creation of the Top Institute Pharma (TI Pharma). The institute’s initial partnerships included a number of global pharmaceutical companies, leading Dutch universities and professional organisations. The Escher FES Project focused on four synergistic areas:
Recently completed Projects
- Pharmacovigilance of biologics
- Improving the EU system for marketing authorization: learning from regulatory practice
Evidence generation methods & evidence requirements
- Biomarkers and assessment of drug efficacy in cardiovascular disease
- Biopharmaceuticals as Challenges to the Regulatory System
- Expert decision making in the European Regulatory Environment
- Innovations in Post-Marketing Safety Research
- Methods to improve the efficiency of confirmatory clinical trials
- Off-target effects of RAAS-inhibition
- Personalized Medicine
- The evaluation of drug regulation
- Decision Making in Drug Regulation
- Drug life cycles and public trust
- Ethical Issues in Postauthorization Drug Trials
- Lessons learned from Escher and CBG-MEB Regulatory Science Projects
- Non-inferiority trials: methodological and regulatory challenges
- Patient involvement in scientific committees in the assessment of benefits and risks of medicinal products
- Regulatory benefit – risk assessment; different perspectives
- Studies on marketing authorization of innovative drugs
- Decision support for benefit-risk assessment with imprecise preference information
- Proof of concept study using the case of aliskiren
- The multiple parameter risk response outcome score
- Making better use of clinical trials
- Patient perspective in the benefit/risk evaluation of drugs
- Decision-making process and benefit-risk assessment
- Adverse drug reactions in Europe
- Evidence for the innovation crisis in pharma
- Access and reimbursement trajectories
- The role of medical need in drug reimbursement decision-making
Scientific Dialogue and Stakeholder Interaction
- Biomarkers and assessment of drug efficacy in cardiovascular disease
- Biopharmaceuticals as Challenges to the Regulatory System
- Expert decision making in the European Regulatory Environment
- Innovations in Post-Marketing Safety Research
- Methods to improve the efficiency of confirmatory clinical trials
- Off-target effects of RAAS-inhibition
- Personalized Medicine
- The evaluation of drug regulation
- Decision Making in Drug Regulation
- Drug life cycles and public trust
- Ethical Issues in Postauthorization Drug Trials
- Lessons learned from Escher and CBG-MEB Regulatory Science Projects
- Non-inferiority trials: methodological and regulatory challenges
- Patient involvement in scientific committees in the assessment of benefits and risks of medicinal products
- Regulatory benefit – risk assessment; different perspectives
- Studies on marketing authorization of innovative drugs
- Decision support for benefit-risk assessment with imprecise preference information
- Proof of concept study using the case of aliskiren
- The multiple parameter risk response outcome score
- Making better use of clinical trials
- Patient perspective in the benefit/risk evaluation of drugs
- Decision-making process and benefit-risk assessment
- Adverse drug reactions in Europe
- Evidence for the innovation crisis in pharma
- Access and reimbursement trajectories
- The role of medical need in drug reimbursement decision-making
The Decision-Making Process and Benefit-Risk Assessment
- Decision support for benefit-risk assessment with imprecise preference information
- Proof of concept study using the case of aliskiren
- The multiple parameter risk response outcome score
- Making better use of clinical trials
- Patient perspective in the benefit/risk evaluation of drugs
- Decision-making process and benefit-risk assessment