Pharmaceutical products are associated with risks that must be managed efficiently to prevent patient harm. Regulatory agencies have mandated risk assessments and safety surveillance for all pharmaceutical products. Risk Management Plans and Risk Mitigation Strategies outline the measures taken to minimize those associated risks with a substance or product. Both sets of procedures detail important activities that maintain patient safety during different life cycle management stages- from research through the market authorization to post-approval monitoring phases. While they differ on how the risk minimization actions will be executed and monitored, they provide the essential guidance that is needed for the appropriate identification and management of patient safety risk associated with a product.
DDReg identifies risks related to substances/products and helps determine pv & risk management strategies and additional requirements necessary for mitigating these risks against patient health that could arise as a result. We ensure a robust & effective risk management plan or risk minimization strategy that act proactively to reduce the probability and the extent of an associated product risk. Our highly experienced team assists MAHs to develop an appropriate Risk Management Plan (RMP) as well as Risk Evaluation & Mitigation Strategies (REMS) that is compliant to the most updated regulatory requirements of EMA or US FDA or other competent authorities.
DDReg PV & Risk management Expertise includes:
- Drafting, reviewing, and maintaining RMPs and REMS while providing support through submission methods
- Preparing customized procedures to classify safety risks and deliver tailored risk management strategies
- Assessment of potential risks and missing information and prepare reports that recommend pv & risk management methods
- Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), such as developing academic materials, observational examinations, and targeted follow-up questionnaires
- Effectively convey risks through labelling means such as Summary of Product Characteristics (SmPC) and patient information leaflet (PIL)