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 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, streamlined procedures, and processes shall be in place at all pharmaceutical companies in the Pharmacovigilance system.
Learning Objectives:
After completion of the training, you will be able to:
- Describe the main principles defined in the ICH E2C(R2) guideline
- Author and review the content and data presentation in aggregate reports
- Handle the regulatory communications in regard 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
This will be a perfect learning opportunity in all areas of drug safety, pharmacovigilance, regulatory and quality compliance and will be a great addition to your knowledge in pharmacovigilance.
Course Content
- Introduction To Aggregate Reports In Pharmacovigilance
- Regulatory Aspects of Aggregate Reports
- Technical Aspects of Drafting Aggregate Reports
- Planning Process and Interdepartmental Responsibilities
- Creating PSUR/PBRER - Introduction
- Creating PSUR/PBRER - Sections 1 - 5
- Creating PSUR/PBRER - Section 6 - 8
- Creating PSUR/PBRER - Section 9 - 14
- Creating PSUR/PBRER - Section 15 - 16
- Creating PSUR/PBRER - Section 17 - 19
- Creating PSUR/PBRER - Appendices & References
- Quality Aspects Of Aggregate Reports
- PSUR Submission Procedure In EU and Other Countries
- PSUR Assessment Procedure - PSUSA
- Post-Assessment Communication And Management
- Inspections And PSUR/PBRER
Course Provider
Sunil Verma,
Director ,
Academy of Clinical IntelligenceSunil 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.
Who Should Attend
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
