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PHARMACOVIGILANCE & RISK MANAGEMENT SUMMIT February 16 17, 2017 Berlin, Germany CURTIS&WYSSBERLIN, GERMANY FEBRUARY 16 17, 2017PHARMACOVIGILANCE & RISK MANAGEMENT SUMMIT Who Should Attend? CEOs, Directors,

How to fill out pharmacovigilance amp risk management

How to fill out pharmacovigilance amp risk management

1. To fill out pharmacovigilance and risk management forms, follow these steps:
2. Begin by gathering all relevant information about the medication or medical device being reported.
3. Familiarize yourself with the specific form or template provided by the pharmacovigilance and risk management system. This may vary depending on the country or regulatory agency.
4. Start by providing basic details such as the name of the product, manufacturer, and batch or lot number.
5. Proceed to list any adverse events or side effects experienced by patients or users of the medication or device. Include details such as the date and time of occurrence, severity, and outcome.
6. Complete any additional sections related to risk assessment, mitigation strategies, and follow-up actions.
7. Double-check all the information for accuracy and completeness.
8. Submit the filled-out form as per the instructions provided by the pharmacovigilance and risk management system.
9. Keep copies of the completed forms for your records and for future reference if needed.

Who needs pharmacovigilance amp risk management?

1. Pharmacovigilance and risk management is essential for various stakeholders involved in the healthcare industry, including:
2. - Pharmaceutical companies: They need to monitor the safety and effectiveness of their products to ensure patient safety and regulatory compliance.
3. - Healthcare professionals: They play a crucial role in reporting adverse events and monitoring the usage of medications or medical devices.
4. - Regulatory agencies: They require pharmacovigilance and risk management systems to assess the safety profile of drugs and medical devices in the market.
5. - Patients and consumers: They benefit from pharmacovigilance and risk management as it helps identify and prevent potential harm from medications or medical devices.
6. - Researchers and scientists: They often use pharmacovigilance data to study the safety and efficacy of various drugs and medical treatments.
7. - Insurance companies and payers: They rely on pharmacovigilance information to evaluate the risk and cost-effectiveness of different treatment options.

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