Safety Data Exchange Agreements (SDEAs) are contracts established to define the roles and responsibilities between organizations regarding the exchange and reporting of patient safety information.
SDEAs, typically owned by Pharmacovigilance (PV) departments, are consistently a focus area in PV inspections by Regulatory Authorities. In recent years, “contracts and agreements” represented a common “Major” or “Minor” finding from PV inspections conducted by the MHRA.
Factors impacting SDEAs
Challenges typically arise from:
- Mergers & Acquisitions (M&As): When companies merge or are acquired, SDEAs have to be updated to comply with corporate standards as well as related standardized procedural documents and have to include the updated company / resource information.
- Business evolution: In global organizations, business relationships are continuously formed, and contracts are signed such as licensing agreements, supply and marketing agreements or distribution agreements. Frequently, the obligations to patient safety are an afterthought, and PV departments must retain oversight of when SDEAs have to be created and ensure that SDEAs are up-to-date on both local and global levels.
- Changing regulatory landscape: Organizations need to ensure that safety related content in SDEAs is compliant with international and national legislation and regulation, depending on the territories and products subject to the contracts.
How Can Navitas Help?
Navitas helps organizations establish oversight and control of SDEAs. We provide insight and support to develop and implement solutions in the following areas:
- Establish a strategic management framework
- Design and implement tailored governance model
- Define standards, mechanisms, and metrics for management oversight
- Clarify roles and responsibilities
- Promote internal cross-functional and external stakeholder collaboration
- Develop procedural documents and SDEA templates
- Design and implement CAPA management processes
- Assess, evaluate, configure, and implement supporting systems
- Consolidate document repositories