Data Exchange Agreement

One of the main reasons for non-compliance with pharmacovigilance is the inadequacy of the SDEA. Routine monitoring of data exchanged according to the SDEA is required. There should be a database for SDEAs for all products, partners, dates of agreements, drugs covered, bonds and documents exchanged, etc. Yes, yes. SDEAs may be requested in the United States for inspection in accordance with EU drug safety legislation and equivalent FDA legislation. They must be drawn up within a specified time frame and, within the EU, they must contain a specific list of key details, such as. B as the details of the qualified person, etc. Our team establishes robust and reliable agreements to ensure that there is a mechanism to obtain the correct data within a mandatory and compliant time frame to ensure that all activities that take place throughout the transit process comply with the rules applicable to them. For a consultation on the SDEAs, please contact the team with confidence on (0)1483 307920; Alternatively, you may prefer an e-mail It is the primary responsibility of the marketing authorization holder to control an ADES and to ensure that no security information falls because of any „gap”.

It is imperative that all data get through, and there is a system of acknowledgment and coordination of data sent and received. 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 source documents. Since this agreement is binding on all partners, the legal department should review and approve the document. Typically, companies develop the SDEA model. An agreement whereby two or more entities agree to exchange one or more data sets and associated attributes so that the information content assigned to the data or its meaning during the transfer is not changed. A security data exchange contract is a legal written contract, which ensures that all safety data relating to a drug is promptly and reliably returned to the holder of the marketing authorization so that he can meet his legal obligations according to the relationships, The SDEA will eventually have to include the attribution of responsibility for the EU QPPV, the PSUR letter, document research, reporting to regulators, answering questions from regulators, processing product claims, signal recognition, hosting the safety database and assessing ongoing benefits. 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. The types of security data obtained may be very different, they may be reports of adverse events, but they may also be other safety data: reports of abuse, abuse, overdose, medication errors, use during pregnancy, inefficiency – and others. The MAH must have a system in place to obtain these reports, third parties must have procedures in place to forward these reports to the MAH, and an ADS must be available to monitor and ensure that no security data falls because of any „gap”.