249 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. Artificial intelligence in European medicines regulation
5. Sharing Is Caring? International Society for Pharmacoepidemiology Review and Recommendations for Sharing Programming Code.
6. The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions
7. Sharing is caring? International Society of Pharmacoepidemiology review and recommendations for sharing of programming code
8. European Medicines Agency seeks stakeholders' views on future transparency measures for clinical trials
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. RCTs and real world evidence are complementary, not alternatives
12. 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
13. Contributors
14. Regulation of Vaccines in Europe
15. Artificial intelligence in European medicines regulation
16. Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works
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. A natural language processing approach towards harmonisation of European medicinal product information
20. 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
21. Is patient exposure preapproval and postapproval a determinant of the timing and frequency of occurrence of safety issues?
22. An algorithm to detect unexpected increases in frequency of reports of adverse events in EudraVigilance
23. Building an Evidence Base on the Place of Industry-Sponsored Programs in Drug Safety Surveillance
24. Registries in European post‐marketing surveillance: a retrospective analysis of centrally approved products, 2005–2013
25. Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention
26. Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection
27. 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
28. A natural language processing approach towards harmonisation of European medicinal product information
29. COVID-19 kick-starts a new era for clinical trials and pandemic preparedness in Europe
30. Periodic Benefit-Risk Evaluation Report: A European Union Regulatory Perspective
31. Can We Rely on Results From IQVIA Medical Research Data UK Converted to the Observational Medical Outcome Partnership Common Data Model?
32. New approaches to strengthen pharmacovigilance
33. The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions
34. Real‐World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value
35. Geographical variation in reporting Interstitial Lung Disease as an adverse drug reaction: findings from an European Medicines Agency analysis of reports in EudraVigilance
36. 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.
37. The US Food and Drug Administration-European Medicines Agency Collaboration in Pharmacovigilance: Common Objectives and Common Challenges
38. Benefit Risk Management Plans?
39. Regulatory Pharmacovigilance in the European Union
40. A Description of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance as a Global Resource for Pharmacovigilance and Pharmacoepidemiology
41. Exploring the opportunities for alignment of regulatory postauthorization requirements and data required for performance-based managed entry agreements
42. The Certainty Framework for Assessing Real-World Data in Studies of Medical Product Safety and Effectiveness
43. A Case Of Laboratory Acquired Brucellosis: A Rare Condition, But Laboratory Transmission Is A Risk
44. The European Medicines Agencyʼs use of prioritised independent research for best evidence in regulatory action on diclofenac†
45. Views from Academia, Industry, and Regulatory Agencies
46. Regulation of vaccines in Europe
47. List of Contributors
48. STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies
49. Increasing the impact of Post Authorisation Safety Studies: transparency is key
50. Exploring the opportunities for alignment of regulatory postauthorization requirements and data required for performance-based managed entry agreements
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