BRACE, health policy, guidance documents

(002) Breaking the Code: Patient Associations' Perception on Adverse Drug Reaction Reporting in Portugal

(003) Building transparency and reproducibility into the practice of pharmacoepidemiology and outcomes research

(004) Challenges of multi-country post-authorisation safety studies for surveillance of new medical products

(005) Challenges, Lessons Learned and Implications for Improvement in Employing Drug Utilization Studies to Evaluate the Effectiveness of Additional Risk Minimization Measures (aRMMs)

(006) Comparative analysis of European healthcare systems: insights for selecting countries when designing Post-Authorization Safety Studies

(007) Comparative Analysis of Medicines Under Additional Monitoring in the European Union and Bulgaria

(008) Comparing regulatory guidance on risk mitigation (or RMM) studies and the Reporting recommendation Intended for pharmaceutical Risk Minimization Evaluation Studies (RIMES) checklist

(009) Completion and reporting rates of paediatric clinical trials conducted as part of an EU Paediatric Investigation Plan.

(010) Comprehensive Analysis of Pharmacovigilance Inspections Practices: Focus on QPPV Responsibilities in the Pharmaceutical Industry in Saudi Arabia

(011) Does Expedited Regulatory Approval Predict the Therapeutic Value of Drugs? A Systematic Review

(012) Drivers and Methodological Considerations Associated with the Acceptability of Real-World Evidence for Effectiveness/Efficacy by Regulators and HTAs: Evidence from North America, Europe, and Australia

(013) Effectiveness of additional risk minimisation measures for valproate among healthcare professionals and patients: a cross-sectional survey in six European countries

(014) Experiences and perceptions of patients and healthcare professionals with advanced practice partnership agreements between Family Medicine Group pharmacists and healthcare professionals

(015) Experts’ opinion on data quality assessments for multi-database pharmacoepidemiologic studies: A qualitative analysis

(016) FDA REMS: Characterizing Burdens and Case Application of a Novel Integrated Ethical Framework

(017) Forging a Path for Transporting Real-World Evidence: Existing Applications & Proposed Practices

(018) Guidelines for the Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in Pharmacovigilance (READUS-PV)

(020) Health Technology Assessment Reports for Non-Oncology Medications in Canada from 2018 to 2022: A comparison Between Manufacturer and Common Drug Review analyses

(021) How to improve Patient centricity in Benefit-Risk Assessments (BRA)?

(022) Impact of Mobile Health (mHealth) Technologies on Medication Adherence and Symptoms Improvement in Patients Receiving Oral Anti-Cancer Agents: A Systematic Review

(023) Impact of pharmacovigilance interventions targeting fluoroquinolones on systemic antimicrobial drug use and health outcomes in the Netherlands

(024) Impact of regulatory interventions on immediate release fentanyl and alternatives use in Spain: an interrupted time-series analysis

(025) Improving the Quality of Drug Safety Review Reports: SFDA Experience

(027) More-EUROPA (More Effectively Using Registries) – A cross-sectional survey assessing evidence needs around the introduction of new medicines

(028) Overview of regulations for INN prescribing and substitution, with implications for the implementation of crossborder ePrescription and eDIspensation services in countries of the European Union.

(029) Patient and Public Involvement in pharmacoepidemiological research: an environmental scan

(030) Pharmacogenomics-Pharmacovigilance Project: SFDA Experience

(031) Proactive Safety Monitoring of Recent Registered Medicinal Products in Saudi Arabia: the SFDA Experience

(033) Review of Pharmacovigilance Practice of Biosimilars in Japan

(034) Scoping Review of the Use of Post-marketing Database Studies (PMDS) as an Additional Pharmacovigilance Activity of Risk Management Plans in Japan

(036) The ICH E9(R1) Estimand Framework in the Context of Real-World Data and Observational Studies

(037) The public health impact of suspending cyproterone acetate (2mg)/ethinylestradiol (35µg) in France: A predictive modelling technique to estimate adverse drug reactions prevented by regulatory action

(038) Unlocking Insights: Lesson Learned from the Tokenization of a Psoriasis Trial

(039) Use of Drug Use Evaluations by Australia’s National Reimbursement Agency to Assess Quality of Medicines Use: A Document Analysis Study

(040) Using Real-World Evidence for Clinical Drug Development to Address the Gap Between Marketing Authorization and Reimbursement in European Countries

(042) What are the main experiences and treatment preferences of people living with achondroplasia and their caregivers?