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This Information Day provides a platform to discuss the implementation experiences of Periodic Safety Update Reports (PSURs) under new pharmacovigilance legislation, including practical experiences and key assessment areas relevant to public health and risk evaluation. The event brings together experts from regulatory agencies and the pharmaceutical industry to share insights and enhance knowledge on PSURs.

How to fill out 2nd periodic safety update

How to fill out 2nd periodic safety update

1. Gather all relevant safety data from the reporting period.
2. Review and analyze the safety data for any emerging safety signals.
3. Compile the findings in a structured format, including a summary of safety concerns.
4. Update the periodic report with any changes in risk management plans or recommendations.
5. Ensure all sections adhere to regulatory requirements for the 2nd periodic safety update.
6. Submit the completed periodic safety update to the appropriate regulatory authority.

Who needs 2nd periodic safety update?

1. Pharmaceutical companies preparing to submit findings after a drug's initial authorization.
2. Regulatory affairs professionals responsible for compliance and submission.
3. Healthcare professionals monitoring ongoing safety of marketed products.

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What is 2nd periodic safety update?

The 2nd periodic safety update is a regulatory document that provides an assessment of the safety of a pharmaceutical product after its second year on the market, summarizing safety data and any new findings.

Who is required to file 2nd periodic safety update?

The marketing authorization holders (MAHs) are required to file the 2nd periodic safety update for their products to the relevant regulatory authorities.

How to fill out 2nd periodic safety update?

To fill out the 2nd periodic safety update, the MAH should collect and analyze safety data, summarize any adverse events, provide updates on benefit-risk analysis, and complete the standard form as per regulatory guidelines.

What is the purpose of 2nd periodic safety update?

The purpose of the 2nd periodic safety update is to ensure ongoing monitoring of the safety and efficacy of a drug, to identify any new risks, and to inform regulatory authorities and healthcare providers.

What information must be reported on 2nd periodic safety update?

The report must include data on adverse drug reactions, changes in the benefit-risk balance, relevant literature, and any additional safety information that has emerged since the last submission.