Depending on the relationship, the AEDS may need to include the assignment of responsibility for the EU QPPV, PSUR letters, desk research, reporting to regulators, responding to regulatory questions, handling product complaints, signal recognition, hosting the safety database, and ongoing assessment of benefits and risks. If some or all of the pharmacovigilance activities are outsourced, including medical information, call centres, adverse event processing, the AEDS should be complete and detail which parties are responsible for which activities, even if the ultimate responsibility lies with the recovery office. None of the above lists are exhaustive – the types of data and activities regulated by AEDS vary from company to company and product to product. • An overview of the types of agreements• The points you need to consider when developing and implementing VPAs • Points to consider and prioritize for quality assurance monitoring • A matrix of typical clauses based on your type of agreement. ■ It is therefore in our interest to prepare this agreement with the utmost care. Outsourcing pharmacovigilance and outsourcing of drug safety and regulatory activities can significantly reduce the costs and workload of any pharmaceutical marketing authorisation (MA) holder. However, overall responsibility and supervision of the pharmacovigilance system remains the responsibility of the Dunct Office and the EU QPPV. In particular, it is the responsibility of the marketing authorisation holder to correctly receive and, if necessary, speed up adverse event and other safety reports. Even when all pharmacovigilance activities are outsourced, the overall responsibility lies with Mahnfa.

The legal and regulatory responsibility for non-compliance with pharmacovigilance legislation by a pharmacovigilance outsourcing provider lies with the order for payment and not with the company to which the pharmacovigilance has been outsourced. Within the European Union (EU), much of the guidance on what should be included in a PVA is listed in Module I1 of Good Vigilance Practices (GMP). The module explains that, while it is acceptable for the marketing authorisation holder to apply certain pharmacovigilance activities to third parties, the marketing authorisation holder retains full responsibility for compliance with those activities and must ensure that mechanisms are in place to allow the Pharmacovigilance Qualified Person (QPPV) to access all relevant information from those sources. The ultimate responsibility for the admonition is one of the reasons for the importance of a thorough PVA to ensure full monitoring of activities. The period of validity of the agreement is also indicated. Often, companies choose the duration of the contract to extend it until it is revised or suspended. Just as a standard operating procedure lists the definitions relevant to its content, so should the pharmacovigilance agreement. This provides a basis for each time a technical term is quoted in the agreement. It is advisable to specify the conditions and extent of liability of all parties in case of damage.

This is highlighted alongside the definition of the applicable law (of a territory or country) governing aspects of the agreement. The SDEAs vary depending on the role played by the 3rd part. If the third party only conducts sales activities, their exposure to security data may only require simple instructions on what to do if they encounter problem reports. If the third party is more involved, a distributor, a co-marketing company, a co-development company or a licensee, the SDEA will be more detailed. If the outsourced activity is pharmacovigilance, the AEDS needs to be even more detailed, as it is essential that all parties involved are aware of their responsibilities and processes for safety reporting. This is a question answered in a recent blog published by the UK`s Medicines and Healthcare Products Regulatory Agency (MHRA). One might think that wholesalers in Europe do not systematically receive information about adverse events (this could be more common in other countries outside the EU). This type of information could be obtained mainly from those involved in parallel imports. However, a wholesaler could potentially obtain safety-related information. And it seems that many are unaware of their responsibilities with this pharmacovigilance (PV) data. This is where a contract can be useful, especially if a wholesaler provides photovoltaic services to the marketing authorisation holder (MAH). Yes.

SDEAs can be requested for inspection in accordance with EU drug safety regulations and equivalent FDA legislation in the United States. They must be created within a certain period of time and, within the EU, they must contain a specific list of the most important details, details e.B. of the qualified person, etc. Our team creates strong and reliable agreements to ensure that there is a mechanism by which the right data can achieve the right objective within a prescribed and compliant time frame, ensuring that all activities that take place throughout the transit process comply with the regulations applicable to them. For advice on AEDS, please contact the team confidentially on +44 (0)1483 307920; Alternatively, you may prefer to email info@primevigilance.com In addition, the MHRA describes the provisions «that the stimulus agent wants to take into account in agreements» on the blog titled Do Wholesalers Need Pharmacovigilance Agreements? Are agreements required for each wholesaler? According to GVP module I1; The collection, processing and management of Individual Case Safety Reports (ICSRs) is an essential pharmacovigilance process. It is therefore imperative that this be included in the PVA. In this section, there are important areas that need to be covered. First of all, it is necessary to define the type of cases collected by each partner (e.B. post-marketing, clinical trials, registries, market studies), as well as whether serious and non-serious cases should be exchanged. It is also necessary to define which party is responsible in which area. Similarly, specific situations and expectations regarding the collection of cases associated with such cases should be clearly defined. All of this is important to ensure that no source of safety data is overlooked and, conversely, that there is no duplication of trap submissions.

The format in which cases are exchanged must also be specified. This is important to ensure that the format is compatible with what the owner of the global PV database needs to import and classify cases. Another crucial element is the establishment of the schedule for the exchange of cases, including a definition of zero day to ensure that there are no misunderstandings between partners. In fact, Module VI2 of the BPV states: «The beginning of the clock for the submission of ICSRs begins with the knowledge of the minimum information by the organization or contractor (whichever comes first).» If this is defined in the PVA, as well as the number of working or calendar days during which the partner must forward cases to the order for payment, the late submission of cases to the regulatory authorities should be minimised. Including such case exchange information, it should be ensured that each undertaking receives the reports it needs to comply with the requirements of the regulatory authority. Communicating changes in the risk of benefit to healthcare professionals (HCPs) and patients is another important process in pharmacovigilance1. Raising awareness of the risks associated with products is fundamental to patient safety. One way to do this is to provide up-to-date product information (Summary of Product Characteristics (SmPC), Package Leaflet (PL) and Packaging). In addition, and according to the Pharmacovigilance Inspection Metrics Report (April 2016 – March 2017)3 of the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA), important findings regarding the maintenance of safety baseline information increased significantly during the reference period.

This section of the PVA should indicate whether there will be a company master data sheet and who will maintain it, as well as who will be responsible for updating local PPSCs. Another important aspect is confirmation of who will be responsible for communicating with regulators and how updates will be shared (both within partner companies and with the public/HCP). .