The types of security data obtained may be very different, they may be reports of adverse events, but they may also be other safety data: reports of abuse, abuse, overdose, medication errors, use during pregnancy, inefficiency – and others. The MAH must have a system in place to obtain these reports, third parties must have procedures in place to forward these reports to the MAH, and an ADS must be available to monitor and ensure that no security data falls because of any « gap ». It is imperative that all data go through, and there must be a system of acknowledgment and coordination of data sent and received. This agreement, including exhibitions and schedules, constitutes the entire agreement between UT and Medtronic on commercialization and replaces all previous agreements or agreements between the parties, unless this agreement replaces the revised and revised development agreement, the security data exchange agreement and the pharmacovigilance agreement. A well-written ADEA ensures that the safety data of a drug collected from all sources is exchanged between the two parties (if any) and ensures that the applicant/market authorization holder can meet its obligations. To this end, companies must enter into written agreements with all parties, businesses, individuals, investigators, CROs, patient support organizations, toxin control centres (when used for AEs registration), telephone call centres and other business partners who receive the security data a company needs. This also applies to all companies listed on labelling, such as distributors, manufacturers, partners, etc. These agreements are referred to as « security data exchange agreements » (SDEAs). They are requested and verified by the FDA and other health authorities during inspections. 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. Other: some companies exchange signals, regulatory safety matches, IRB/EC security comments and requirements, data protection committee results, security withdrawals from the market, new decisions or requirements of health authorities, preclinical safety issues, etc.