Safety Data Exchange Agreement Novo Nordisk

Health and Safety We employ more than 43,000 people worldwide. They all have a fundamental right to a healthy and safe working environment. Supporting their physical health and psychological well-being is fundamental for them to develop personally and professionally. As a healthcare company, we process large amounts of personal data, including information about clinical trial participants, human biological sample donors, patients and healthcare providers who report safety issues and our employees. The SDEA vary according to the role performed by the 3rd party. If the third party only conducts sales activities, their exposure to safety data may require only simple instructions on what to do if problem reports occur. If the third party is more involved, a distributor, a co-marketing, a co-development or a licensee, the SDEA will be more detailed. Where the outsourced activity is a pharmacovigilance activity, the AEDDs need to be even more detailed, as it is important that all parties involved are aware of their responsibilities and processes for safety reporting. · Contact details such as telephone number, e-mail ID for the communication of security details We regularly conduct risk checks by exchanging information with external collaborators. The investigation of suspected cases of counterfeiting is reported through our affiliated companies or authorities. Monthly internal reports on counterfeit monitoring are checked by leading specialists and management. Ownership of the global security database must be established in advance and interoperability of different security databases must be ensured. It is also necessary to reach agreement on the format of the receipt document (source documents, e2b, MedWatch, CIOMS, etc.).

Working with a third party that specializes in all of these elements may prove to be the best solution in such scenarios. The role of the Pharmacovigilance Specialist at Novo Nordisk – integrated into the global research and development safety department – is to ensure the safety of patients who use our pharmaceutical products during our clinical trials and during the marketing of our products. By competently performing safety data analyses and medical evaluations, pharmacovigilance specialists play a crucial role in the success of clinical trials and, ultimately, in the availability of safe and effective medicines for patients around the world. Other problems may arise from the inability of the parties to justify specific requirements. This can lead to frequent changes in procedures, and if the agreement contains many details at the operational level and how an SOP is written, frequent updates to the agreement are required. Yes. SDEAs can be requested for inspection in accordance with EU drug safety rules and equivalent FDA laws in the UNITED States. They must be drawn up within a set period of time and include a specific list of key details within the EU, for example.B.