Gvp Agreement

The records must be available for the order for payment regardless of the participation of third parties, including in the event of termination of the contract, transfer of services or acquisition of a product by change of ownership8. In the event of loss of data or unavailability of derived datasets, it may be necessary for the notice to reconstitute its safety database in order to fulfil its pharmacovigilance obligations and therefore MAH may wish to retain copies (including clear datasets not publicly available) to cover the risk of business continuity. The parties should agree on the procedures and rules applicable to the retention of records (timing, archiving and destruction) and ensure that this complies with legal requirements. Contracts and agreements should contain a language ensuring that, in areas where records and pharmacovigilance data are held exclusively by a third party, the timely provision of records and data for audits, inspections or investigations by the competent authority can be ensured. If a marketing authorisation holder has entrusted some of its pharmacovigilance tasks to subcontractors, the placing on the market remains responsible for the application of an effective quality system for those tasks. It may be appropriate for service providers and MAHs to conduct joint gap analyses and capacity planning, and agreements should provide for oversight mechanisms, including independent audits. Scope is the key to defining the conditions for the rest of the agreement. Within the scope, the products and territories covered by the VPA (and by which party) can be defined. However, it may be easier to have this detailed information in an appendix to the agreement if the products/areas covered are bulky and subject to frequent changes. Another area that could be included in the scope is to define the role of each party. An example could be the confirmation of the part of the MAH and which one is the distributor? Are the parties the two MAH, but in different areas? Or maybe the distributor is also the local MAH? This information helps the reader understand the requirements of each party.

Another point to be included in this section could be the language in which the information should be exchanged. This is an important point, as partner companies may have branches in countries that speak different languages. It is therefore necessary to choose a common language. Account should also be taken of the party transmitting the information to the regulatory authorities and the language applied by the regulatory authorities in an area. According to CSDP Module I1; The planning, preparation and filing of periodic safety update reports (PSRUs) is another critical pharmacovigilance process. Similarly, Development Safety Reports (DSUS) are essential for pharmacovigilance in clinical trials. This is therefore another important aspect of any VPA. One of the reasons given is the obligation to provide aggregated notifications to regulatory authorities within specified time limits. If this requirement is not met, an inspection may be triggered.

In addition, the aggregated reports are subject to a thorough assessment by the authorities and a lack of partner safety data could be found, which will trigger a subsequent administrative inspection. The VPA section on aggregate reporting should define responsibilities in the preparation of the report; Who writes the report, what are the tasks of the supporting part (for example. B provide sales data). This is important to ensure that the report constitutes the overall availability of safety data. In addition, auditors and review schedules should be defined and the report approved. The definition of all this data in the VPA prior to the preparation of the report should ensure that the process runs smoothly (without duplication) and that each party currently has sufficient time to verify and enter the report before being submitted. . .