Harom Solutions

INTERNATIONAL CONFERENCE ON HARMONIZATION (ICH)

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
E2B(R3) IWG - Implementation: Electronic Transmission of Individual Case Safety Reports
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

E2E - Pharmacovigilance Planning

E2F - Development Safety Update Report

GOOD PHARMACOVIGLANCE PRACTICES (GVP MODULES)

Module I – Pharmacovigilance systems and their quality systems
Module II – Pharmacovigilance system master file
Module III – Pharmacovigilance inspections
Module IV – Pharmacovigilance audits
Module V – Risk management systems
Module VI – Management and reporting of adverse reactions to medicinal products
Module VII – Periodic safety update report
Module VIII – Post-authorisation safety studies
Module VIII addendum I – Member States' requirements for transmission of information on non-interventional post-authorisation safety studies
Module IX – Signal management
Module X – Additional monitoring
Module XV – Safety communication
Module XVI – Risk minimisation measures - Selection of tools and effectiveness indicators

FOOD & DRUG ADMINISTRATION (21 CFR Part 11)

§ 11.1 - Scope.

§ 11.2 - Implementation.

§ 11.3 - Definitions.

§ 11.10 - Controls for closed systems.

§ 11.30 - Controls for open systems.

§ 11.50 - Signature manifestations.

§ 11.70 - Signature/record linking.

§ 11.100 - General requirements.

§ 11.200 - Electronic signature components and controls.

§ 11.300 - Controls for identification codes/passwords.

CENTRAL DRUG STANDARD CONTROL ORGANIZATION (CDSCO)

COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES (CIOMS)

CIOMS Working Group I - International Reporting of Adverse Drug Reactions
CIOMS Working Group II - International Reporting of Periodic Drug-Safety Update Summaries
CIOMS Working Group III - Guidelines for Preparing Core Clinical-Safety Information on Drugs
CIOMS Working Group IV - Benefit-Risk Balance for Marketed Drugs: Evaluating Safety Signals
CIOMS Working Groups V - Current Challenges in Pharmacovigilance: Pragmatic Approaches

THE COMPLIANCE