Menu Back to Poster-Presentations-Details

PP01-18: Effectively Managing Oversight of Responsibilities in Safety Data Exchange Agreements to Ensure Regulatory Compliance

Poster Presenter

      Marina Suvakov

      • Director, Compliance and Business Management, Global Pharmacovigilance (GPV)
      • Otsuka
        United Kingdom


An SDEA written between a marketing authorization holder (MAH) and a third party outlines their respective pharmacovigilance (PV) responsibilities. Our aim was to develop a robust governance model to eliminate deficiencies in SDEA management, in order to ensure contractual and regulatory compliance.


The process was streamlined by introducing a governance framework that supports a unified approach to track and manage SDEAs through cross-functional collaboration and compliance monitoring. Data pertaining to SDEA-related audit findings and compliance metrics were analyzed for 2016–2019.


The detailed analysis of all active SDEAs against the Master Service Agreements (MSAs) revealed that approximately 60% of SDEAs were invalid or redundant. These were subsequently consolidated or terminated. Automation was introduced for monthly reconciliation of Otsuka’s Contract Repository, to ensure the SDEAs are aligned with MSAs. In addition to reducing the time for analysis and report generation (by 94%), the automation tool provided higher accuracy and minimized manual intervention. Updating the SDEA template improved consistency across all SDEAs, and streamlining the process enabled an accurate reflection of the business relationship. This was achieved by identifying appropriate roles/responsibilities of cross-functional key stakeholders; including non-PV functions in the review/approval process. The introduction of project plans to manage reviews helped to mitigate delays associated at various stages of development and increased accountability across the functions. The use of a globally accessible repository in lieu of emails for cross-functional reviews allowed transparency and provided a consolidated draft. Maintenance of SDEAs was further enhanced by introduction of a unified tracking system to ensure adherence of commitments and regular reviews. Monthly monitoring of cumulative ICSR Exchange Compliance per SDEA timelines identified dips in compliance from the tolerance threshold. Tracking of cases, which were late from partners that delayed Heath Authority submission highlighted non-compliance and prevented future recurrence. The success of compliance monitoring allowed an increase in the tolerance threshold of ICSR exchange with partners from 80% to 85%.Retrospective data analysis revealed up to 88% reduction in open findings and substantial improvement in the compliance percentage of ICSR exchange with business partners from 78% to 89%. No major findings from internal/external audits in 2019 further indicated the success of the implemented practices.


As SDEAs are key focus areas in routine inspections and deficiencies in SDEAs have been seen as major contributors to inspection findings, it was essential to develop a robust governance model to appropriately manage and maintain the oversight to enable compliance with regulatory obligations of Marketing Authorization Holders (MAH). The biggest challenge and reward in streamlining the process was the introduction of cross-functional involvement of multiple stakeholders, which also included non-PV functions (business units, legal etc.). This ensured the status of the business relationship was accurately reflected, and in turn strengthened the intercompany collaborations with functions involved in the alliance. The tailored governance model for SDEA monitoring, in conjunction with an integrated approach for preparation and communication, empowered Otsuka in managing SDEAs and the relationship with a multitude of partner companies (>35). Monitoring the compliance metrics as per the established tolerance thresholds, and exchanging this information with partners at pre-determined frequencies through meetings/email communications; helped to strengthen the collaboration by aiding timely escalations and preventing potential delays affecting regulatory compliance. The process improvement also facilitated the closure of pending open findings and corrective and preventive actions (CAPAs) from audits/inspections related to SDEAs in a timely manner. Overall, this unified approach followed for tracking SDEAs, automating reconciliation processes, and formulating value-added analysis of compliance to SDEA commitments ensured that measures were put in place to detect non-compliance in a timely manner so that CAPAs can be expedited. It can be concluded that experiential learning and capacity building through cross-functional information sharing with MAHs are critical for achieving a successful relationship between MAHs to ensure inspection readiness and regulatory compliance