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Best Practices For Developing, Managing and Reporting of PSURs/PBRERs in Pharmacovigilance - Webinar

  • ID: 4759708
  • Webinar
  • March 2019
  • Region: Global
  • 90 Minutes
  • Academy of Clinical Intelligence

PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorization. (European Medicines Agency)
The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product, taking into account new or emerging safety information in the context of cumulative information on risk and benefits. (European Medicines Agency)

In November 2012, the ICH recommended Periodic Benefit Risk Evaluation Report (PBRER) was mandated by European Union (EU) in a new PSUR to manage and evaluate the post-authorization safety benefit-risk profile of a medicinal product.
The main objective of a PBRER is to present a comprehensive, concise, and critical analysis of new or emerging information on the risks of the medicinal product, and on its benefit in approved indications, to enable an appraisal of the product’s overall benefit-risk profile.(ICH)

To develop consistent standards for meaningful benefit-risk assessments, a streamline procedures and processes shall be in place at all pharmaceutical companies in the Pharmacovigilance system.

At the conclusion of this tutorial, participants will be able to:

  • Describe the main principles defined in the ICH E2C(R2) guideline
  • Describe the structure, content and data presentation in aggregate reports
  • Handle the regulatory communications in regards to PSUR/PBRER with regulatory authorities
  • Understand the key challenges in PSUR/PBRER sections and how to address them
  • Understand the procedure and timelines of PSUR/PBRER submission
  • Avoid the critical Inspections findings related to PSUR/PBRER
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Course Summary:

  • Principles defined in the ICH E2C(R2) guideline
  • Structure and content
  • Data presentation and line listings
  • Authoring and Reviewing a PSUR/PBRER
  • Solutions for overcoming challenging PSUR/PBRER sections
  • Responding to feedback from PRAC and regulatory authorities
  • Submission of safety variations following signal and PSUR assessment outcome
  • Understanding of PSUR assessment report and PSUR outcomes
  • Benefit-Risk Assessment in PSUR: Discussion on Practices
  • PSUR submission with cover page and timelines
  • Corrigendum to the PSUR – When and How
  • Latest PSUR related Inspection Findings – How to avoid yours
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  • Sunil Verma Sunil Verma,
    Director ,
    Academy of Clinical Intelligence

    Sunil has been in the Clinical Research Industry for over 10 years. He held the position of Director of Trainings for a leading Contract Research Organization, HAROM Solutions. His company facilitates the business sector by providing Pharmacovigilance services to Pharmaceutical companies and technical trainings to Medicine, Dental, and Pharmacy, Life Science professionals internationally in the fields of Pharmacovigilance, Clinical Research, and Medical Writing etc. He has been involved in trainings throughout his career particularly in the areas of Pharmacovigilance including ARGUS Safety, Clinical Research and Medical Writing. With over 10 years of experience in the pharmaceutical industry and clinical research organization, Sunil offers his clients the assurance that their drug safety training programs are being conducted by a seasoned pharmacovigilance executive with experience in developing, implementing and leading safety trainings in lower cost markets.

    Sunil was formerly Manager, Trainings & Operations of Clinical Research and Pharmacovigilance, where he successfully developed and led more than 8 therapeutic area teams and support training and operations functions for the management of Clinical Data and Adverse Event reporting for human health, including all phases of a product life cycle (drugs, vaccines and devices). Sunil is a client certified trainer with expertise in techno-functional training on Oracle Argus Safety 7.0 including Argus activities, User management, Case processing including duplicate check, case book-in, follow up, coding, medical review, reports generating (Expedited, Aggregated, PSUR) and dashboard reports. He ahs proficiency in WHO-DD and MedDRA Dictionary and knowledgeable in various regulatory guidelines like ICH guidelines, Good Clinical Practices, Good Documentation Practices and Volume 9A etc.


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All Professionals are involved in:

  • Pharmacovigilance (including QPPV)
  • Clinical Research
  • Risk Management
  • Drug Safety Assessment Department
  • Safety Data Analysis
  • Pharmacoepidemiology
  • Information Technology
  • Regulatory Affairs
  • Pharmacovigilance consultancy
  • Quality and Compliance
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