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Periodic Safety Update Report PSUR

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The planning of pharmacovigilance activities to characterize and quantify clinically relevant risks and to identify new adverse reactions in the ‘periodic safety update report PSUR.

How to build an Effective Periodic Safety Update Report PSUR

An effective pharmacovigilance planning must contain the following factors to make it successful:

  • Monitor the occurrence of identified risks post-approval
  • Categorize new and unidentified risks that were not deceptive in clinical development
  • Increase an understanding of ‘real world use’ vs clinical study use
  • Deliver more information and characterize the safety profile of the medicine.

PSUR Strategic Level Audit Planning 

Our main purpose of the periodic safety update report PSUR is to create a comprehensive and critical analysis of the risk and benefit analysis of the product considering new or developing safety information in the context of cumulative data on risk and benefits. This evaluation should determine whether further investigations need to be implemented to the product information or marketing authorization.

The audit strategy of PSUR in pharmacovigilance comprises the governance, risk management, and internal controls of all parts of the pharmacovigilance system, including:

  • All pharmacovigilance processes and tasks.
  • Guideline on good pharmacovigilance practices
  • Synergies and boundaries with other departments, as suitable.
  • Pharmacovigilance activities are directed by affiliated organizations or delegated to another organization.

Moreover, In the pharmacovigilance procedure, audit criteria should imitate the requirements for the pharmacovigilance system. Also, ensure that the quality method for pharmacovigilance activities is found in the legislation and guidance.

In the past years, the PV changed histrionically. However, a Periodic Safety Update Report (PSUR) is a pharmacovigilance document created to offer an update of the global safety experience of a medicinal product to regulatory authorities at a specific time point post-authorization. Our experts provide extensive practical and hands-on experience in all aspects of pharmacovigilance and safety risk management. Therefore, Drug Safety Solutions offer up-to-date and in-depth knowledge and expertise in this industry that includes:

  • Signal Detection
  • Pharmacoepidemiology
  • PV Systems Development and Implementation
  • PV Audits
  • Implementation of EU PV legislation

FAQs About Periodic Safety Update Report PSUR

What should a PSUR strategy contain?

A PSUR strategy must include:

  • The emerging information new signal, any identified risks.
  • The summary of safety and efficacy information of the medicine.
  • Integrated risk-benefit analysis of all authorized indications.
  • Complete conclusion of risk minimization measures.
  • The outline plan of signals or risk evaluation.

What are the sources of safety information? 

The best sources of safety information are:

  • Active surveillance system
  • Clinical trial data
  • Unpublished manuscripts
  • Competent authorities update and website publications
  • Non-clinical data updates
  • Spontaneous reports and case studies
  • Post authorization adopt in a particular population
  • Investigation of product quality.

When should you need to submit PSUR?

The PSUR submission timelines are within 60 days after authorization. Although, the MAH is responsible for informing the agency of the date of the original placing of the product on the market of the European Union.