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Synowledge’s risk management program begins with the assessment and identification of risks and potential risks associated with a product. Based on these risks, Synowledge works with clients to develop risk reduction goals with the implementation of a risk management plan. Our team helps clients to proactively review, and monitor, the risk profile of products, and supply metrics to measure the results and effectiveness of risk management plans.
When a product meets the FDA requirements for a Risk Evaluation and Mitigation Strategies (REMS), A REMS strategy is implemented to manage a known or potential serious risk associated with a drug or biological product. Certain products previously approved/licensed with risk minimization action plans (RiskMAPs) will now be deemed to have REMS. If a product’s profile meets the requirements for a REMS, Synowledge can help with its development and implementation. If additional risk minimization activities are needed, Synowledge can also help with the development of:
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- Risk Assessments
- Medication Guide
- Patient Package Insert
- A Communication Plan
- Mechanisms to restrict use of the product
- Elements to ensure safe use
- An implementation system to monitor, evaluate, and improve the implementation of the elements (including a timetable for assessment of the REMS) required where elements to assure safe use are specified.
Synowledge can also assist in the development of:
- Educational materials, such as brochures, patient information, check-lists, and pharmacist guides
- Training programs
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