Guidelines for Pharmacovigilance Safety Data Exchange Agreements (SDEA)
1) Purpose
The purpose of this SOP is to outline procedures for establishing and managing Safety Data Exchange Agreements (SDEAs) related to pharmacovigilance activities.
2) Scope
This SOP applies to all pharmacovigilance personnel responsible for negotiating, implementing, and maintaining SDEAs, including pharmacovigilance managers, legal advisors, and regulatory affairs specialists.
3) Responsibilities
The SDEA Management Team is responsible for ensuring that SDEAs are established and maintained in compliance with regulatory requirements. This includes coordinating with internal stakeholders and external parties to ensure effective safety data exchange.
4) Procedure
4.1 SDEA Negotiation and Execution
- Identify the need for an SDEA based on regulatory requirements and business agreements.
- Conduct negotiations with relevant parties (e.g., marketing authorization holders, distributors) to finalize SDEA terms and conditions.
- Review legal and regulatory implications of SDEA terms with legal advisors and regulatory affairs team.
- Execute SDEA and ensure all parties involved understand their obligations regarding safety data exchange.
4.2 Pharmacovigilance Obligations under SDEA
- Define pharmacovigilance responsibilities, including reporting requirements, data exchange procedures, and communication protocols.
- Establish mechanisms for receiving and processing safety data from relevant parties in compliance with SDEA provisions.
- Ensure timely and accurate exchange of safety data to support ongoing pharmacovigilance activities.
4.3 Compliance Monitoring and Auditing
- Monitor adherence to SDEA terms and conditions by conducting regular compliance checks.
- Conduct internal audits and inspections to assess the effectiveness of SDEA implementation and adherence to regulatory requirements.
- Address any deviations or non-compliance issues identified during audits promptly and appropriately.
4.4 Amendment and Termination
- Review and update SDEAs as necessary to reflect changes in regulatory requirements or business agreements.
- Negotiate amendments to SDEAs with relevant parties and execute revised agreements.
- Manage the termination of SDEAs in accordance with contractual obligations and regulatory requirements.
4.5 Documentation and Record Keeping
- Maintain comprehensive records of all SDEAs, including negotiation outcomes, executed agreements, and any amendments or terminations.
- Archive SDEA documentation in compliance with company policies and regulatory retention requirements.
5) Abbreviations, if any
SDEA – Safety Data Exchange Agreement, PV – Pharmacovigilance, SOP – Standard Operating Procedure
6) Documents, if any
Safety Data Exchange Agreements (SDEAs), compliance monitoring reports, audit findings.
7) Reference, if any
EU Good Pharmacovigilance Practices (GVP) Module V – Risk Management Systems, FDA Guidance for Industry – Safety Reporting Requirements for INDs and BA/BE Studies.
8) SOP Version
Version 1.0
