July 22, 2024
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or more parties.
Such contractual agreements may be set-up between license partners or service providers during the development or the post marketing phase.
They are aimed to ensure compliance with the legal requirements and to have appropriate and reliable safety data available to ensure patient safety.
Where the marketing authorisation holder has set up contractual arrangements with a person or an organisation, explicit procedures and detailed agreements should exist between the marketing authorisation holder and the person/organisation to ensure that the marketing authorisation holder can comply with the submission of valid Individual Case Safety Reports (ICSRs) within the appropriate time frames. These procedures should specify the processes for the exchange of safety information, including the timelines and responsibilities for the regulatory submission of valid ICSRs. They should be organised in order to avoid the submission of duplicate ICSRs to the competent authorities.
Where contractual arrangements are made with a person/organisation to perform literature searches and/or submit valid ICSRs, detailed agreements should exist to ensure that the marketing authorisation holder can comply with its regulatory submission obligations.
SDEAs can be requested for inspection both under FDA legislation and the EU drug safety regulations. Within the EU, the SDEA needs to include at a minimum, but not exclusively, name and contact details of the Qualified Person Responsible for Pharmacovigilance (QPPV), each party responsibility with regard to literature surveillance, ICSR collection and submission to concerned authorities, PSUR writing and submission, RMP, Signal detection and management, response to safety requests from Competent Authorities.
A process needs to be established to receive the contractual details and agreed rights between the parties prior to drafting any SDEA/PVA. Good communication and continuous interaction between PV and functions initiating or reviewing contracts is key for this. Such functions maybe located in Business Development for licensing agreements, Medical Affairs for PSP, IIT, PASS, NIS, clinical operations for clinical trial supply, Medical Information for call centre or sales reps agreements, procurement for vendor agreements. Many pharmaceutical companies have a policy that their legal department or attorney needs to review all agreements, so it maybe helpful to train such a function to always reach out to PV for relevant contracts to have an expert reviewing those contracts to determine if it requires a PVA/SDEA.
Based on the licensing situation or the contracted PV service certain elements for an effective SDEA/PVA shall be described in such a document. The SDEA/PVA template and checklists may help to create such a comprehensive document. Make sure that all aspects and all stakeholders are included to provide content to the specific situation.
A negotiation and escalation process are helpful to get the drafted SDEA/PVA finalised and signed. Important stakeholders (e.g. the QPPV) and decision makers shall be involved, as well.
Once the SDEA/PVA is finalised a robust implementation process is key to ensure that everyone concerned is following the arrangements and the PSMF is updated accordingly.
Finally, an oversight tool, which could be simply a Pharmacovigilance System Master File Annex, an excel table or a contract database can help the set-up, implementation and maintenance of SDEAs/PVAs.
In the complex landscape of drug development and marketing, SDEAs and PVAs play a crucial role in ensuring that safety data is accurately managed and regulatory requirements are met. These agreements provide a structured approach to pharmacovigilance, outlining clear responsibilities and processes for all parties involved. By adhering to the guidelines and best practices discussed, pharmaceutical companies can enhance their compliance, improve patient safety, and streamline their pharmacovigilance operations.
Effective management of SDEAs and PVAs requires thorough planning, robust communication, and continuous oversight. Leveraging templates, checklists, and experienced personnel can significantly aid in the creation, negotiation, and implementation of these agreements. Ultimately, a well-executed SDEA/PVA not only protects patients but also supports the integrity and reputation of the pharmaceutical company.
If you need assistance with setting up or managing SDEAs or PVAs, contact ProPharma for expert guidance and support. Our team of experienced professionals is here to help ensure your compliance with regulatory requirements and safeguard patient safety.
Vice President, QPPV Office
Senior Consultant Pharmacovigilance, Alliance Management
TAGS: LPPV QPPV Pharmacovigilance Safety Data Exchange Agreements (SDEA) Pharmacovigilance Agreement (PVA)
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