When Is A Pharmacovigilance Agreement Required
Communication of Risk Changes: Benefits for Health Professionals (HCPs) and Patients are another important process of pharmacovigilance1. Awareness of product risks is essential for patient safety. One way to do this is to provide up-to-date product information (product characteristics summary (Smpc), patient brochure (PL) and packaging). In addition, according to the report of the pharmaceutical inspection Metrics (April 2016 – March 2017)3 of the British Medicines and Health Products Regulatory Authority (MHRA), the main results for maintaining reference safety information have increased significantly over the period under review. This section of the VPA should indicate whether there will be a company background sheet and who will manage it with who is responsible for updating local PMS. Another important aspect is to confirm who is responsible for communicating with regulators and how updates are shared (both within partner companies and with the public/HCPs). If the carefully defined data is not sufficiently defined, then even if the updates are completed, the information may not reach patients and HCPs in all areas where the product is marketed. If the update is motivated by the regulator that addresses one of the parties, notification deadlines should be set to the other party, as well as a dispute resolution clause regarding the reaction to the regulator. This provision should be defined so that the most appropriate party (i.e. the MAH or the company in the territory where the authority`s application was made) can communicate effectively with the Authority. 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).