Technical Training on Writing, Managing and Reporting Of PSURS/PBRERS In Pharmacovigilance

Academy of Clinical Intelligence (ACI)

Certificate

Online

₹ 45,000 VAT incl.

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Description

  • Type

    Certificate

  • Methodology

    Online

  • Duration

    12 Weeks

  • Internship

    Yes

  • Virtual classes

    Yes

ACI in collaboration with HAROM Solutions provide technical training program on “DEVELOPING, MANAGING AND REPORTING OF PSURs/PBRERs IN PHARMACOVIGILANCE”. The program includes 12 weeks of training incorporate the unique technicalities and experience combined from our extensive team of industry professionals. The technical training with live experience on the drafting, reviewing and managing the PSUR/PBRER gives the opportunity for candidates to excel in their Pharmacovigilance career.
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.

About this course

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 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

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

B. Pharm | M. Pharm
MSc Lifesciences (any)
BDS | MDS
MBBS | MD
BSc Nursing

The only training platform make the participants skilled in writing and managing PSUR/PBRER in Pharmacovigilance
A specially designed program for working professionals to learn at their on ease through the next generation online training platform

Once contacted, the students shall receive the detailed brochure of the training program along with enrollment details.

• This recorded, self-paced learning provides 24/7 access to practical, hands-on training on all the modules. Through the training content, practice exercises and assignments, and a final assessment, participants complete the training with a strong background of the regulatory requirements of the Indian Pharmacovigilance system.

Each module is for approx 90 minutes.

Yes, the training access will be for the period of 12 weeks for each user. You can complete the course at your own pace.

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Reviews

Subjects

  • Pharmacovigilance
  • PSUR
  • PBRER
  • ICH
  • EU
  • Analysis
  • Reporting
  • Writing
  • Evaluation
  • Risk
  • Managing
  • Aggregate
  • Safety Management
  • ICSR
  • WHO
  • Pharmaceutical
  • Drug Research
  • Medicine
  • Training and Development
  • Career Development

Teachers and trainers (1)

Sunil Verma

Sunil Verma

Director – Pharmacovigilance Training (Corporate Services)

Mr. Sunil Verma is the Founder & CEO of ACI, a reputed and fastest growing Pharmacovigilance Training Management Company with national and international presence. ACI delivers Pharmacovigilance Professional Training Programs for fresher and also has strong base in corporate training services across emerging markets. ACI is rated amongst the top training company globally for its quality systems and compliance. For the last 5 years, Mr. Sunil has focused on delivering high quality training service to fresher, Pharmaceutical and CROs in Pharmacovigilance.

Course programme

· 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

Additional information

TRAINING RECOGNITION & ACCEPTANCE: WHO Pharmacovigilance Guidelines International Conference on Harmonization Good Pharmacovigilance Practices Modules TAKE AWAYS: Training completion certificate Recommendation letter for candidates with good performance in training 

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Technical Training on Writing, Managing and Reporting Of PSURS/PBRERS In Pharmacovigilance

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