In short, companies need to have security exchange agreements in place to fully comply with the rules. The other key groups involved in SDEA are the Business Development People. Even in small businesses, these people can be easily identified and informed of PV and security requirements for business transactions. In large companies, this can be more difficult, especially when the head or manager of each subsidiary has the power to do business without necessarily bringing it to the Home Office. Often, such agreements fall through the grid. To this end, companies must enter into written agreements with all parties, companies, individuals, investigators, CROs, patient support organizations, poison control centers (when used to collect ESAs), call centers, and other business partners who could obtain security data that a company needs. These include all companies mentioned in the label, such as distributors, manufacturers, partners, etc. These agreements are called Safety Data Exchange Agreements (SDEAs). They are requested and verified by the FDA and other health authorities during inspections. As the SDEA is a binding written agreement between the partners, the Legal Service should review and approve the document. It is sometimes included in a framework (service) contract or agreement. It is sometimes treated as a separate document between drug safety groups. Sometimes the framework contract has a short boilerplate section (see below).
INTERACTIVE MEETING – Discussion and verification of key standard clauses: co-marketing and distribution agreements In many companies, the legal department knows all the partners involved in the marketing of the 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 had more than 10,000 contracts in about 110 countries around the world. There may be a database with them or not. You can live in several places around the world and many are not in English. In my experience, legal departments are happy to help with medication safety in AEDS, but often they don`t know all the contracts around the world themselves. Sometimes the finance department is best informed about all the deals around the world, because they have to send and receive money! It`s a smart idea to develop one or more boiler trays that can be inserted into all contracts and agreements. They should be developed with the legal department and requested by the Business Development Group so that they are automatically added to all contracts. This is not unusual, as most contracts contain several clauses that are boilerplates covering other issues such as insurance, liability, etc. This course is intended to give you an overview of the need for the nature and use of pharmacovigilance agreements and to make you understand the content of a pharmacovigilance agreement. Other: some companies exchange signals, regulatory correspondence on safety issues, IRB/EC safety comments and requirements, data oversight committee results, market withdrawals for safety issues, new decisions or requirements of health authorities, preclinical safety issues, etc.
The incoming flow and management of this security information is governed by Security Data Exchange Agreements (SDEAs) and is prescribed by law in all cases where security data may be received by third parties, i.e. not by the licensee. Depending on the singularity of the business relationship that the partner might have, some particular reflections should be undertaken….