1.0 Qualified Person Responsible for Pharmacovigilance (QPPV) | 4 | ||
1.1 | Name of EU QPPV | 4 | |
1.2 | Address of Site Where EU QPPV Is Based | 4 | |
1.3 | Curriculum Vitae and Description of Responsibilities of the EU QPPV | 5 | |
1.4 | Backup Procedure to Apply in the Absence of the EU QPPV | 5 | |
1.5 | Outside Office Hours | 5 | |
1.6 | Contact Persons for Pharmacovigilance at National Level | 6 | |
1.7 | Companies to Which This Pharmacovigilance System Master File Applies and for Which the EU QPPV Provides Services | 8 | |
2.0 Organizational Structure of the Marketing Authorization Holder | 10 | ||
2.1 | Company Structure and Operating Model for Pharmacovigilance | 10 | |
2.1.1 Company Profile | 10 | ||
2.1.2 Overview of Pharmacovigilance Management | 11 | ||
2.2 | Contractual Arrangements with other Persons and Organizations Involved in the Fulfillment of Pharmacovigilance Obligations | 15 | |
3.0 Sources of Safety Data | 18 | ||
3.1 | Inflow of ADRs and Safety Information | 18 | |
3.2 | Processing of ICSRs | 20 | |
3.3 | Outflow of Safety Data to EU Authorities | 22 | |
4.0 Computerized Systems and Databases | 22 | ||
4.1 | Validation and Maintenance | 22 | |
4.2 | Responsibility for the Operation of the Application and Its Location | 23 | |
4.3 | Backup and Failover | 23 | |
5.0 Pharmacovigilance Processes | 23 | ||
5.1 | Continuous Monitoring of Product Risk-Benefit Profile | 23 | |
5.2 | Risk Management System | 24 | |
5.3 | ICSR Collection, Collation, Follow-Up, Assessment, and Reporting | 25 | |
5.4 | PSUR Scheduling, Production, and Submission | 25 | |
5.5 | Communication of Safety Concerns | 26 | |
5.6 | Implementation of Safety Variations to the SmPC and PIL | 27 | |
6.0 Pharmacovigilance System Performance | 28 | ||
7.0 Quality System | 29 | ||
7.1 | General Overview | 29 | |
7.2 | Document and Record Control | 30 | |
7.3 | Procedural Documents | 31 | |
7.4 | Training | 31 | |
7.4.1 List of PharmaCo PV Locations in EU | 31 | ||
7.4.2 Summary Description of Training | 32 | ||
7.5 | Audits | 33 |