Safety Data Exchange Agreement Example

There is no “one size fits all” SDEA, although they are usually similar. In fact, that`s the catch. For large companies, any agreement can be a “single agreement” in which there are small, but real, differences between the agreements. For example, you may need to send source documents to Company A before Day 3 and to CIOMS I before Day 8. for company B until day 2 or day 10; for C MedWatchs for US business and CIOMS I for ex-US day 5 for SUSARs and day 8 for all other SAEs, etc. In other words, each is different enough to impose different procedures for each partner. In large companies that receive more than 100,000 AEs/SAEs per year, and in dozens to hundreds of partners, this poses serious operational problems. #PVA #SDEA #agreements #contracts #pharmacovigilance #drugsafety The clauses and obligations that must be covered by the VPA depend on the nature of the business relationship that exists between the partners. To achieve the main objective, the POC must ensure that the basic elements such as the type of security data, format, timing, flow direction and database medium are clearly defined in the agreement. It should be clearly defined when providing information, in collaboration with nature and the party.

It should also ensure that there are mechanisms such as periodic votes (or other similar mechanisms) that ensure that all necessary data is shared by the “issuing party” with the “receiving party” and that all data that has been attempted to be transmitted has been received. There should also be clearly defined timetables for the implementation of this activity. Provision should also be made for staff training, on-site audits, prior notifications, derogations and CAPAs that respond to regulatory requests and their defined individual deadlines. Details such as denunciations, arbitration procedures, jurisdictions, contact details should also be mentioned in the agreement as well as the necessary authorisations. On the basis of the criticism of the commitments assumed by the non-MAH parties, the aspects related to the business continuity plans should be defined and examined and included in the relevant clauses of the agreement. As this Agreement is binding on all partners, the Legal Service should review and approve the document. . .

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