Risk management reports
Risk management plans (RMP) showcase current knowledge about the safety and efficacy of a therapy, providing vital information on plans to gather knowledge, e.g. studies, and measures to mitigate or prevent associated risks. Qinecsa supports the preparation and submission of comprehensive RMPs in both EU GVP Module V format and other non-EU formats.
Develop comprehensive RMPs to monitor and manage potential safety issues and mitigate risks for patients.
Systems
Qinecsa has well-developed clinical and administrative systems, processes, and reports employed to identify, monitor, evaluate, mitigate, and prevent risks pertaining to medicinal products.
Risk Evaluation and Mitigation Strategies
REMS include a risk mitigation goal and are comprised of information communicated to and/or required activities to be undertaken by one or more participants who prescribe, dispense, or take the medication.
Submission
Version controlled and dated RMPs should be provided in CTD section 1.8.2. in one single PDF-file so that a complete RMP is provided to the European’s Medicines Agency (EMA).