Safety Data Exchange Agreements (SDEAs) are an integral part of the collaboration we see in the pharmaceutical industry these days. Where multiple companies work together to develop and market drugs and devices, large amounts of information are collected by a sometimes staggering number of different organisations. Somehow this data – including adverse events, aggregate reports and other monitoring findings – needs to be accessible to all parties, accounted for in a central database and also meet the regulatory requirements of each and every country involved in the marketing of the product.
SDEAs are complex to say the least and unfortunately, the way companies sometimes find out that their SDEAs are inadequate is when something goes wrong. Similarly, our client experience has taught us that SDEA deficiencies are a common audit / inspection finding, SDEAs cannot be an afterthought. Rather, a SDEA should be a well-planned, structured document. The Commercial Eyes Drug Safety group has a comprehensive understanding of the various regional regulatory requirements and is well equipped to produce SDEAs to ensure compliance, no matter how many marketing partners are involved. We also recommend that Sponsors have in place policy and governance documents covering SDEAs, something we are able to assist with.
Our experts know what’s required and can take the complexity out of SDEAs, ensuring that whether you know the intricacies of SDEA requirements or not, your product is compliant. To discuss your Safety Data Exchange Agreement requirements, give our Drug Safety Manager Jim Malliaros a call on +61 4 9251 0777.