AEDSs are written contracts between two or more parties that work together to define each party`s responsibilities for each pharmacovigilance activity. A well-drafted agreement ensures regulatory compliance and prevents duplication of pharmacovigilance activities by different partners. A safety data exchange agreement is a legal written contract that ensures that all safety data relating to a medicinal product is returned promptly and reliably to the marketing authorisation holder so that it can comply with its legal obligations. in which security data can be obtained from third parties, required by law. Party – that is, not the licensee. 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. SDEAs can be requested for inspection under FDA and EU drug safety regulations. Within the EU, the SDEA must at least, but not exclusively, provide the name and contact details of the qualified person responsible for pharmacovigilance, any party responsible for the literature analysis, collection and submission of DIRS to the relevant authorities, drafting and submission of the PSUR, the PGR, the recognition and management of signals, the response to requests from the competent authorities, which deal with complaints. etc.
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. Since this agreement is binding on all partners, the Legal Service must review and approve the document. Typically, companies are developing the SDEA model. · Contact details such as telephone number, e-mail ID for communication of security details The agreement between the marketing authorisation holder and the distributor as well as the agreement with a MAH licensing partner or a cross-licensing partner are the most critical, as there is a high chance of obtaining safety data from the distributor`s side, the MAH license partner or cross-license partner. The main actors in the implementation of SDEA are lawyers. All contracts are (or certainly should be) approved by the legal department. The processing of safety data varies somewhat between the US, the EU and other regions, but in general the obligation to speed up safety reporting of suspected serious adverse reactions to the competent authorities is at least similar in all areas.
The time frame within which reports are to be received begins upon receipt of the report by the subcontractor/outsourcing provider of the 3rd party, NOT when the report reaches the MAH. Therefore, it is in the interest of the reminder that the reports are transmitted to him (or to the provider) in order to reach them as quickly as possible so that they can be processed correctly and on time. 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. It is primarily the responsibility of the marketing authorisation holder to have an AEDS to monitor and ensure that no safety data falls through “gaps”. It is imperative that all data passes and that there is a system of acknowledgment of receipt and reconciliation of sent and received data.
This applies to both clinical trials and post-market situations, as well as special programs such as patient support programs. Some companies only want MedWatch or CIOMS I forms for each case, others also want the source documents. Security Data Exchange Agreements (SDEAs) are written legal contracts that ensure that all safety data for a licensed product is promptly and reliably returned to the Marketing Authorization Holder (MAH) so that it can comply with its legal obligations to aggregate safety data and submit safety reports in a timely manner. Companies must have security exchange agreements in place to ensure regulatory compliance. 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 drawn up within a certain period of time and, within the EU, they must contain a specific list of the most important details, e.B. details of the qualified person, etc. Our team creates strong and reliable agreements to ensure that there is a mechanism in place for the right data to achieve the right objective within a prescribed and compliant timeframe to ensure that all activities that take place throughout the transit process comply with the regulations that apply to them.
For advice on AEDS, please contact the team confidentially on +44 (0)1483 307920; Alternatively, you may prefer to send an email info@primevigilance.com One of the main reasons for non-compliance with pharmacovigilance is the shortcomings of the SDEA. Routine monitoring of data exchanged in accordance with the SDEA is required. A database of AEDS for all products should be maintained, listing partners, agreement data, medicines covered, obligations and documents exchanged, etc. The types of safety data obtained can be very different, it can be reports of adverse events, but also other safety data: reports of abuse, abuse, overdose, medication errors, use during pregnancy, lack of effectiveness – and others. The recovery must have a system in place to receive these reports, the 3rd party must have processes in place to submit these reports to the recovery notice, and there must be an AEDS in place to monitor and ensure that no safety data falls through “gaps”. It is essential that all data passes, and there must be a system of acknowledgment of receipt and reconciliation of data sent and received. In the case of an updated periodic security report (PSUR), the date used as the reference date for. In addition, there must be a follow-up of companies that violate agreements by sending reports late or not sending reports at all. How to identify a company that is located in a remote location and does not send serious adverse events is another tricky issue and involves working with the company`s quality and audit groups. SDEAs are created between different stakeholders, such as: All SDEAs must be part of the MAH`s quality management system, and the drafting, approval and documentation of each SDEA and each type of SDEA must follow the company`s SOPs and be verifiable. This is a regulatory requirement and AEDS are inspected during pharmacovigilance inspections and audits. · Defining Terminology and Communication Language Safety Data Exchange Agreement: Maintaining Life Sciences Compliance with AI in Pharmacovigilance – Reinventing Patient Safety · Responsibility for regulatory inspections for PV · Exchange of medical or product inquiries and quality complaints – timelines, format and responsibilities · Information on the pharmacovigilance management system Assessment of product complaints and ensuring vigilance in the pharmaceutical industry through semantic search.
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