DUBLIN–(BUSINESS WIRE)–The “Best Practices For Developing, Managing and Reporting of PSURs/PBRERs in Pharmacovigilance” webinar has been added to ResearchAndMarkets.com’s offering.
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
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
Agenda
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
For more information about this webinar visit https://www.researchandmarkets.com/r/1rxhp
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