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.
Pharmacovigilance Risk Management Plan and Strategy
Risk management plans are essential to identify, assess, and mitigate known and potential safety concerns throughout a product’s lifecycle. These comprehensive reports ensure that benefits continue to outweigh risks while providing regulatory authorities with evidence of robust safety monitoring and management systems.
At Qinecsa, we specialise in developing high-quality risk management documentation that bridges scientific rigour with regulatory compliance. Our experienced medical writers craft clear, concise, and thorough risk management reports including:
- Risk Management Plans (RMPs)
- Risk Evaluation and Mitigation Strategies (REMS)
- Risk Minimisation Plans
- Risk-Benefit Assessment Reports
- Risk Management System documentation
Strategic Risk Minimisation and Management
Our dedicated team of experts focus on developing a robust risk management framework and pragmatic risk minimisation measures tailored to specific safety concerns and managing evolving benefit-risk profile of a product. From routine pharmacovigilance activities to additional risk minimisation interventions, our recommendations balance regulatory expectations with real-world considerations to ensure effective risk management and managing public health.
We understand that risk management is an evolving process requiring ongoing assessment and adjustment. Our reports will also monitor the effectiveness of risk minimisation activities and use structured approaches to evaluate emerging safety data throughout the product lifecycle.
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).
Working with Qinecsa for Your RMP Needs
Our flexible report and management services adapt to your specific needs. Whether you require new risk management documentation, updates to existing reports, or strategic advice on risk minimisation approaches, we prioritise understanding your product’s unique safety profile to deliver tailored, effective, risk management solutions.
