Safety Data Exchange Agreement Deutsch

Posted by on Oct 5, 2021 in Non classé | No Comments

In these considerations, the agreement on the exchange of safety data plays a central role in all areas of the collection, evaluation and reporting of safety data in a given pharmacovigilance system. They shall also ensure that the party concerned has all the necessary safety data for the product concerned and shall assist counterparties and mah to effectively and easily fulfil their pharmacovigilance obligations. In general, the pharmacovigilance obligations of counterparties are limited to a limited number of clauses in framework contracts, given the completeness of the details. It is the responsibility of the local pharmacovigilance representative of the PQppV, in order to ensure that pharmacovigilance obligations are clearly defined for both parties. In an organized setting, this responsibility is assigned to a dedicated PVA/SDEA role. 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.

A Safety Data Exchange Agreement is a legal written contract that ensures that all safety data for a medicine is returned promptly and reliably to the marketing authorisation holder so that they can fulfil their legal obligations The processing of safety data varies slightly between the US, the EU and other areas, but in general, the obligation is to provide safety reports on suspected serious adverse reactions to the competent Bs at least similar in the territories. The time frame within which reports are to be received begins when the report has been received by the third-party subcontractor/outsourcing, AND NOT when the report reaches the MAH…