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REGISTRATION FORM Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Virtual Training Course using the EudraVigilance System #20508 0610 July 2020 Virtual Format Cancellation

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How to fill out eu individual case safety

01

Gather all relevant information about the individual case, including patient information, product name, and adverse event.

02

Access the EudraVigilance system and select 'Create Individual Case' to begin the reporting process.

03

Fill out all required fields accurately and completely, including details on the patient, the product, and the adverse event.

04

Verify the information provided is correct before submitting the individual case report.

05

Follow up on any additional requests or queries from regulatory authorities regarding the case.

Who needs eu individual case safety?

01

Healthcare professionals, such as doctors and pharmacists, who encounter adverse events related to medicinal products in the EU.

02

Pharmaceutical companies and manufacturers who need to report individual cases of adverse events for their products in the EU.

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What is eu individual case safety?

Eu individual case safety refers to the reporting and monitoring of individual cases of adverse reactions or any safety concerns related to a medicinal product within the European Union.

Who is required to file eu individual case safety?

Marketing authorization holders, healthcare professionals, and patients/consumers are required to file eu individual case safety reports.

How to fill out eu individual case safety?

Eu individual case safety reports can be filled out online through the EudraVigilance database or submitted through the national competent authorities.

What is the purpose of eu individual case safety?

The purpose of eu individual case safety is to monitor and evaluate the safety profile of medicinal products, detect any potential risks, and facilitate prompt regulatory action to protect public health.

What information must be reported on eu individual case safety?

The information that must be reported on eu individual case safety includes the patient's details, the adverse reaction(s) experienced, the medicinal product(s) involved, and the reporter's contact information.

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