Gvp Agreement

Posted: December 10, 2020 in Uncategorized

MHRA recommends that organizations (service providers and MAHs) jointly enter into agreements that, in addition to describing specific pharmacovigilance tasks, limit the potential for outsourcing-related pharmacovigilance failures. According to CEP module I1; Another important pharmacovigilance process is the planning, establishment and reporting of periodic safety updates (PSRRs). Similarly, Developmental Safety Update (DSUR) reports are essential for pharmacovigilance in clinical trials. This is another important aspect of each VPA. One reason for this is the requirement to submit aggregate reports to regulators within certain time frames. If this requirement is not met consistently, an inspection may be initiated. In addition, aggregate reports are subject to extensive review by the authorities and the lack of security data from partners has been identified, which has triggered a subsequent inspection of the Authority. Under the Aggregate Reporting Section of the APV, reporting responsibilities need to be defined; who will write the report, what are the tasks of the support party (for example. B provision of sales data). This is important to ensure that the report represents the global availability of security data.

In addition, auditors and audit deadlines should be set and it should be determined who will approve the report. The definition of all this in the VPA prior to the development of the report should ensure that the process proceeds smoothly (without duplication) and that each party has sufficient time for verification and introduction into the report prior to presentation. Finally, it is necessary to define the part responsible for the submission (and, if necessary, the electronic electronic technical documentation formatted electronic prior (eCTD). Careful documentation of these delays will allow timely reporting to regulators. If there are areas covered by the agreement and located outside the EU, reports and requirements in those areas should also be taken into account. The choice of the most appropriate party to deal with this issue (perhaps the party present in the EU territory) is important to ensure that all local requirements are met. Registrations must be made available to the MAH 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. When data is lost or derivative datasets are no longer available, it may be necessary for MAH to rebuild its security database to meet its pharmacovigilance obligations and, therefore, MSOs may retain copies (including unique datasets that are not publicly available) to cover the risk of business continuability. Contracting parties should agree on procedures and rules for keeping records (delays, archiving and destruction) and ensure that this remains in compliance with legal requirements.

Contracts and agreements should include a language that ensures that, where registrations and pharmacovigilance data are kept exclusively by a third party, the timely availability of records and data necessary for the examination, inspection or inspection of the competent authority can be ensured. When a marketing authorization holder has assigned some of his pharmacovigilance tasks to subcontractors, THE MAH retains responsibility for the application of an effective quality assurance system for these tasks. It may be appropriate for service providers and MAHs to conduct a common analysis of gaps and capacity planning, and agreements should include oversight mechanisms, including independent audits.

Comments are closed.