Practical activity that is associated with the identification, assessment, understanding and prevention of adverse negative effects, or any other issue relevant to the drug.
Every company cares about its reputation and in accordance with international standards should provide measures for the collection, analysis and dissemination of information processing on the occurrence of adverse events associated with the use of its products in all territories.
You do not have the time and resources for this – we can help you with providing the following:
- The organization and functioning of a local system for monitoring the safety of products with the role of an organization-authorized for safety in accordance with your company’s standards and the requirements of local legislation
- Development of documentation for a local monitoring system for the safety of products
- Collection and processing of spontaneous reports
- Maintaining a database and reconciling received and processed data
- Maintenance of submission of information to authorized bodies and subsequent communication
- Periodic reporting
- Screening of the literature
- Maintenance of monitoring system audits by local authorized bodies and your internal audit system
- Training of your staff
We can guarantee strict confidentiality in the handling of information and respect for intellectual property rights