Safety Data Exchange Agreements (SDEAs)

The QPPV should have oversight of the global safety profile of the MAH’s medicinal products. Competent authorities want reassurance that safety information is exchanged effectively between different departments (e.g., Regulatory and Pharmacovigilance), between affiliate and headquarter companies and from one end of your organisation (for instance, your distributor in the Middle East) to the other (e.g., your US headquarters), and that the QPPV will be updated with all safety issues and emerging safety concerns in real time.

These are aspects that are frequently scrutinized (and found wanting) at an inspection. To ensure that global safety information is available at a central point within the EEA, DADA can assist in the creation of safety data exchange agreements: documents shared by business partners (associated manufacturers, marketing partners, distribution networks or vendors) that establish clear responsibilities, communication channels and methods for the exchange of safety information.