All CAS should be exchanged within 15 days schedule so that, in most jurisdictions, an expedited report can be submitted under the 15-day requirement. There should be a database for all ADEDs for all products, partners, dates of agreements, drugs covered, bonds and documents exchanged, etc. Depending on its relationships, the SDEA may include the attribution of responsibility for the EU QPPV, the PSUR letter, literary research, reporting to regulatory authorities, answering questions from regulators, processing product claims, signal recognition, hosting the security database and continuous assessment of profit-related risks. Where some or all of the pharmacovigilance activities are outsourced, including medical information, call centres, treatment of undesirable undesirables, the ADES must be complete and specify which parties are responsible for which activities, although the ultimate responsibility lies with the MAH. None of the above lists are exhaustive – the types of data and activities regulated by the ADES differ from company to company and from product to product. At least, the ADES should allow for a rapid exchange of all serious adverse events (CAS) to determine if expedited notification is required. This applies to both clinical and post-marketing trial situations as well as specific programs such as patient assistance programs. Some companies only want MedWatch or CIOMS I forms for each case; Others also want source documents. Since the SDEA is a binding written agreement between the partners, the legal department should review and approve the document. Sometimes it is included in a master contract (service) or contract.
It is sometimes treated as a separate document between anti-drug groups. Sometimes the master`s contract has a short boxing section (see below). As a general rule, this boiler platform is not sufficient to cover all issues and a sentence should be added indicating that the parties will launch a formal and detailed written SDEA within 6 days of signing the contract. The « xx » depends on when patients are exposed to the product. A safety exchange mechanism must be put in place before a patient receives a drug. There are specific considerations to be made depending on the uniqueness of the business relationship that the partners could maintain. To list a few, there could be a scenario whereby there is a « zero VPA » for the business relationship that does not justify sharing security information. In such cases, POC cannot ignore the full mention of the clause; on the contrary, it should be clearly justified in the trade agreement and/or stand-alone VPA clause (sometimes for other activities).
Sometimes the original owner of the product has to take a step backwards because of his own restrictions or regulatory constraints in that particular area to get the MA in his own name. In such scenarios, the MAH would be in the name of the counterparty, which would act as the face of the product only when it comes to submitting legislation and all other activities are carried out by the former party. This situation is delicate and should not be confused with a scenario for regular service providers. Other specific considerations include merger/transfer and piggyback scenarios, which must be treated with the utmost care, taking into account all factors of influence. The inflow and management of this security information is governed by security data exchange agreements (ADSs) and is a legal requirement in all cases where security data can be received by third parties, not by the licensee. It is a smart idea to develop one or more radiators that can be inserted into all contracts and agreements.