Safety Data Exchange Agreements Template

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The SDEAs vary depending on the role of the third part. If the third party only carries out sales activities, their exposure to security data may only require simple instructions on what to do if they run into problems. If the third party is more involved, a distributor, co-marketing companies, co-developer companies or licensees, the SDEA will be more detailed. If outsourced activity is pharmacovigilance, ADEDs need to be more detailed, as it is essential that all parties involved are aware of their security reporting responsibilities and processes. The processing of security data varies somewhat between the United States, the EU and other areas, but, in general, the obligation to expedite security reports on suspected serious adverse events to the relevant authorities is similar, at least from areas. The period during which reports are to be received begins when the report is received by the third-party/subcontracting provider, NOT when the report reaches the MAH. It is therefore in the interest of the MAH that the reports be forwarded to them (or to the service provider) in order to obtain them as quickly as possible, so that they can be processed properly and on time. For a periodic security update report (PSUR), the date is the reference date for… The agreements should contain a certain provision to ensure that the provisions of the document are properly made. These may include periodic audits, votes, meetings or conference calls, etc. There should be a database for all ADEDs for all products, partners, dates of agreements, drugs covered, bonds and documents exchanged, etc. Outsourcing pharmacovigilance and allocating drug safety and regulatory activities can significantly reduce costs and workload for each marketing authorization holder (MAH).

However, overall responsibility and monitoring of the pharmacovigilance system remains the responsibility of the MAH and the EU QPPV. In particular, it is the MAH`s responsibility to properly receive the process and expedite reports on adverse events and other safety reports if necessary. Although all pharmacovigilance activities are outsourced, overall responsibility lies with the MAH.

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