Regulatory Guidelines at יואל קסלר .com

Pharmacovigilance

Regulatory Guidelines at יואל קסלר .com

We have added this regulatory page @ יואל קסלר.com which discusses good pharmacovigilance practice (GVP) guidelines including modules related to signal management, ICSR, risk management plans, risk minimization activities and more. There is also information on GCP, CTA regulations and guidance for safety monitoring in clinical trials.

EMA Regulatory Guidelines at יואל קסלר .com

Pharmacovigilance Guidelines at Regulatory Guidelines at יואל קסלר .com

Signal Detection
- EMA – GVP Module IX – Signal Management (Rev 1)
- EMA – GVP Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions
- EMA – Signal Management
- EMA – IME List
- EMA – DME List
- EMA – PRAC Recommendations on signals
- CIOMS WG VIII – Practical Aspects of Signal Detection in Pharmacovigilance
- MedDRA – Standardized MedDRA Queries (SMQs)

Benefit-Risk Evaluation
- CIOMS WG IV – Benefit-Risk Balance for Marketed Drugs: Evaluating Safety Signals
- CIOMS WG VIII – Practical Aspects of Signal Detection in Pharmacovigilance
- CIOMS WG IX – Practical Approaches to Risk Minimisation for Medicinal Products
- CIOMS WG X – Evidence Synthesis and Meta-Analysis for Drug Safety

ICSR Management
- EMA – GVP Module VI – Collection, management and submission of reports of suspected AR
- ICH E2D – Post-approval safety data management – definitions and standards for expedited reporting
- ICH E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
- CIOMS WG V – Current Challenges in Pharmacovigilance: Pragmatic Approaches
- Duplicate Manegement:
  - EMA – GVP Module VI Addendum I – Duplicate management of suspected adverse reaction reports
- Coding of Adverse Drug Reactions:
  - MedDRA Points to Consider
- Causality Assessment:
  - The WHO Causality Assessment

PBRER, PSUR
- EMA – GVP Module VII – Periodic Safety Update Reports
- ICH E2C (R2) – Periodic Benefit-Risk Evaluation Report

DSUR
- ICH E2F – DSUR
- CIOMS VII – DSUR Harmonizing the Format and Content for Periodic Safety Report during Clinical Trials: Report of CIOMS Working Group VII

Investigator Brochure
- ICH E6(R2) – Good Clinical Practice
- ICH E2F – DSUR
- CIOMS III and V – Guidelines for Preparing Core Clinical-Safety Information on Drugs Second Edition – Report of CIOMS Working Groups III and V

CCSI, CCDS Concept
- EMA – GVP Module VII – Periodic Safety Update Reports
- ICH E2C (R2) – Periodic Benefit-Risk Evaluation Report
- CIOMS III and V – Guidelines for Preparing Core Clinical-Safety Information on Drugs Second Edition – Report of CIOMS Working Groups III and V