E1: Clinical Safety for Drugs used in Long Term Treatment
E1: The Extent Of Population Exposure To Assess Clinical Safety for Drugs intended for long term treatment of non-life threatening conditions.
E2A-E2F: Pharmacovigilance
E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
E2B(R3): Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs)
E2B(R3): Q&As Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
E2B(R3): EWG/IWG Electronic Transmission of Individual Case Safety Reports (ICSRs)
E2C(R2): Periodic Benefit-Risk Evaluation Report
E2C(R2): Q&As Questions & Answers: Periodic Benefit-Risk Evaluation Report
E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
E2D(R1): EWG Post Approval Safety Data Management: Definition and Standards for Expedited Reporting
E2E: Pharmacovigilance Planning
E2F: Development Safety Update Report
E3: Clinical Study Reports
E3: Structure and Content of Clinical Study Reports
E3: Q&As (R1) Questions & Answers: Structure and Content of Clinical Study Reports
E4: Dose-Response Studies
E4: Dose-Response Information to Support Drug Registration
E5: Ethnic Factors
E5(R1): Ethnic Factors in the Acceptability of Foreign Clinical Data
E5: Q&As (R1) Questions & Answers: Ethnic Factors in the Acceptability of Foreign Clinical Data
E6: Good Clinical Practice
E6(R2): Good Clinical Practice (GCP)
E6(R3): EWG Good Clinical Practice (GCP)
E7: Clinical Trials in Geriatric Population
E7: Studies in Support of Special Populations: Geriatrics
E7: Q&As Questions & Answers: Studies in Support of Special Populations: Geriatrics
E8: General Considerations for Clinical Trials
E8(R1): General Considerations for Clinical Trials
E9: Statistical Principles for Clinical Trials
E9(R1): Addendum – Statistical Principles for Clinical Trials
E10: Choice of Control Group in Clinical Trials
E10: Choice of Control Group and Related issues in Clinical Trial
E11-E11A: Clinical Trials in Paediatric Population
E11(R1): Addendum – Clinical Investigation of Medicinal Products in the Paediatric Population
E11A: EWG Paediatric Extrapolation
E12: Clinical Evaluation by Therapeutic Category
E12: Principles for Clinical Evaluation of New Antihypertensive Drugs
E14: Clinical Evaluation of QT
E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non- Antiarrhythmic Drugs
E14 Q&As (R3): Questions & Answers: The Clinical Evaluation of QT/QTC Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
E14/S7B IWG: Questions & Answers: Clinical and Nonclinical Evaluation of QT/QTC Interval Prolongation and Proarrhythmic Potential
E15: Definitions in Pharmacogenetics/Pharmacogenomics
E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
E16: Qualification of Genomic Biomarkers
E16: Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions
E17: Multi-Regional Clinical Trials
E17: General principles for planning and design of Multi-Regional Clinical Trials
E18: Genomic Sampling
E18: Genomic Sampling and Management of Genomic Data
E19: Safety Data Collection
E19: A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials
E20: Adaptive Clinical Trials
E20: EWG Adaptive Clinical Trials
E21: Inclusion of Pregnant and Breastfeeding Individuals in Clinical
E21: informal WG Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials
