226 results on '"Arlett, Peter"'
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2. Accelerating clinical trials in the EU (ACT EU): transforming the EU clinical trials landscape
3. HARmonized Protocol Template to Enhance Reproducibility of Hypothesis Evaluating Real-World Evidence Studies on Treatment Effects: A Good Practices Report of a Joint ISPE/ISPOR Task Force
4. The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions
5. Artificial intelligence in European medicines regulation
6. Sharing is caring? International Society of Pharmacoepidemiology review and recommendations for sharing of programming code
7. European Medicines Agency seeks stakeholders' views on future transparency measures for clinical trials
8. RCTs and real world evidence are complementary, not alternatives
9. Guide to active vaccine safety surveillance: Report of CIOMS working group on vaccine safety – executive summary
10. Study Design and Evaluation of Risk Minimization Measures: A Review of Studies Submitted to the European Medicines Agency for Cardiovascular, Endocrinology, and Metabolic Drugs
11. Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works
12. Contributors
13. Regulation of Vaccines in Europe
14. Artificial intelligence in European medicines regulation
15. A natural language processing approach towards harmonisation of European medicinal product information
16. HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real‐world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force
17. Patient Reporting in the EU: Analysis of EudraVigilance Data
18. HARmonized Protocol Template to Enhance Reproducibility (HARPER) of Hypothesis Evaluating Real-World Evidence Studies on Treatment Effects: A Good Practices Report of a Joint ISPE/ISPOR Task Force
19. Is patient exposure preapproval and postapproval a determinant of the timing and frequency of occurrence of safety issues?
20. An algorithm to detect unexpected increases in frequency of reports of adverse events in EudraVigilance
21. Building an Evidence Base on the Place of Industry-Sponsored Programs in Drug Safety Surveillance
22. Registries in European post‐marketing surveillance: a retrospective analysis of centrally approved products, 2005–2013
23. Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention
24. Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection
25. HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real‐world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force.
26. COVID-19 kick-starts a new era for clinical trials and pandemic preparedness in Europe
27. Periodic Benefit-Risk Evaluation Report: A European Union Regulatory Perspective
28. Can We Rely on Results From IQVIA Medical Research Data UK Converted to the Observational Medical Outcome Partnership Common Data Model?
29. New approaches to strengthen pharmacovigilance
30. The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions
31. Real‐World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value
32. Geographical variation in reporting Interstitial Lung Disease as an adverse drug reaction: findings from an European Medicines Agency analysis of reports in EudraVigilance
33. The US Food and Drug Administration-European Medicines Agency Collaboration in Pharmacovigilance: Common Objectives and Common Challenges
34. Benefit Risk Management Plans?
35. Regulatory Pharmacovigilance in the European Union
36. A Description of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance as a Global Resource for Pharmacovigilance and Pharmacoepidemiology
37. A Case Of Laboratory Acquired Brucellosis: A Rare Condition, But Laboratory Transmission Is A Risk
38. The European Medicines Agencyʼs use of prioritised independent research for best evidence in regulatory action on diclofenac†
39. STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies
40. Increasing the impact of Post Authorisation Safety Studies: transparency is key
41. Exploring the opportunities for alignment of regulatory postauthorization requirements and data required for performance-based managed entry agreements
42. Views from Academia, Industry, and Regulatory Agencies
43. Regulation of vaccines in Europe
44. List of Contributors
45. Does additional monitoring status increase the reporting of adverse drug reaction s ? An interrupted time series analysis of EudraVigilance data
46. Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth
47. What are the patients' and health care professionals' understanding and behaviors towards adverse drug reaction reporting and additional monitoring?
48. The Certainty Framework for Assessing Real‐World Data in Studies of Medical Product Safety and Effectiveness
49. The Role of Pharmacoepidemiology in Regulatory Agencies
50. Pharmacovigilance in Europe: direction of travel in a changing environment
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