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Standard Operating ProceduresActive Pharmacovigilance Surveillance: Drug Safety Monitoring for New Medicines and Novel Regimens of the National TB Program in the PhilippinesDepartment of HealthRevision

How to fill out active pharmacovigilance surveillance

How to fill out active pharmacovigilance surveillance:

1. Start by gathering all relevant data and information related to the drug or medical product. This includes information about its usage, adverse events, and any other relevant safety concerns.
2. Use a standardized reporting form or database to record the gathered information. Make sure to fill out all the required fields accurately and completely.
3. Include details about the adverse events or safety concerns, such as the date of occurrence, severity, suspected causality, patient information, and any actions taken in response.
4. Ensure that the reporting form is submitted within the specified timeframe according to regulatory requirements. This timeframe may vary depending on the severity of the adverse events or the type of safety concern.
5. Keep copies of all submitted reports for your records, and maintain a tracking system to monitor the progress of each report.

Who needs active pharmacovigilance surveillance:

1. Pharmaceutical companies: It is the responsibility of pharmaceutical companies to monitor the safety and effectiveness of their drugs or medical products. They need active pharmacovigilance surveillance to identify and assess any adverse events or safety concerns associated with their products.
2. Regulatory authorities: Regulatory authorities, such as the FDA in the United States or the EMA in Europe, require active pharmacovigilance surveillance to ensure the continuous evaluation of drug safety. They rely on the information gathered through surveillance to make regulatory decisions, such as drug approvals, label updates, or even drug recalls.
3. Healthcare professionals: Healthcare professionals play a crucial role in identifying and reporting adverse events to ensure patient safety. They need active pharmacovigilance surveillance to stay updated with the latest safety information and contribute to the overall monitoring of drug safety.
4. Patients and consumers: Patients and consumers also have a role in active pharmacovigilance surveillance. They are encouraged to report any adverse events or safety concerns they experience or observe, as their input can provide valuable insights into the safety of drugs or medical products.

In conclusion, active pharmacovigilance surveillance requires thorough and accurate documentation of adverse events and safety concerns. It is important for pharmaceutical companies, regulatory authorities, healthcare professionals, and patients to actively participate in pharmacovigilance activities to ensure the ongoing monitoring and improvement of drug safety.

For pdfFiller’s FAQs

What is active pharmacovigilance surveillance?

Active pharmacovigilance surveillance is the systematic monitoring of the safety of marketed medications to proactively identify and assess adverse effects.

Who is required to file active pharmacovigilance surveillance?

Marketing authorization holders (MAHs) are required to submit active pharmacovigilance surveillance reports.

How to fill out active pharmacovigilance surveillance?

Active pharmacovigilance surveillance reports should include information on adverse events, measures taken to address them, and any updates on the medication's safety profile.

What is the purpose of active pharmacovigilance surveillance?

The purpose of active pharmacovigilance surveillance is to continuously monitor the safety of medications post-marketing to ensure patient safety.

What information must be reported on active pharmacovigilance surveillance?

Information on adverse events, risk management plans, and any updates on the medication's safety profile must be reported on active pharmacovigilance surveillance.

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