Safety Data Exchange Agreement Definition

by admin on April 11, 2021

At least, the ADES should allow for a rapid exchange of all serious adverse events (CAS) to determine if expedited notification is required. This applies to both clinical and post-marketing trial situations as well as specific programs such as patient assistance programs. Some companies only want MedWatch or CIOMS I forms for each case; Others also want source documents. In many companies, the legal department knows all the partners involved in the marketing of companies` products. In large companies that sell hundreds of drugs in more than a hundred countries, there can be tens of thousands of such contracts! This was certainly the case in one of the large companies where I worked for many years. We have had more than 10,000 contracts in approximately 110 countries around the world. Maybe there`s a database with them. You can live in several places around the world and many are not in English. In my experience, legal services are happy to help with drug safety with ADES, but they often know nothing about all the contracts that exist in the world. Sometimes the financial department is better informed of all agreements around the world, because they have to send and receive money! As a general rule, this boiler platform is not sufficient to cover all issues and a sentence should be added indicating that the parties will launch a formal and detailed written SDEA within 6 days of signing the contract.

The “xx” depends on when patients are exposed to the product. A safety exchange mechanism must be put in place before a patient receives a drug. 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. The legal and regulatory responsibility for any failure of a pharmacovigilance provider to properly comply with pharmacovigilance legislation rests with the MAH, not with the company to which pharmacovigilance has been outsourced. SDEAs are written contracts drawn up between two or more cooperations to define the responsibilities of each party by referring to each pharmacovigilance activity. A well-developed agreement ensures compliance with the legislation and prevents the doubling of pharmacovigilance activities by different partners.

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. There should be a database for all ADEDs for all products, partners, dates of agreements, drugs covered, bonds and documents exchanged, etc. Worse, if the agreement is signed and the security service is not informed of the new partner or the new drug. I remember receiving a CAS for a product that none of us could know about in the security group.

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