Pharmacovigilance aggregate writing certification course

Practical Pharmacovigilance aggregate writing course, DSUR PBRER/PSUR PADAR, CSR patient safety narrative, Drug Safety,

Aggregate reporting involves preparation and submission of safety reports for a given medicinal product to worldwide regulatory agencies and constitutes an essential part of safety monitoring of a medicinal product.

Aggregate report writing refers to preparing periodic, structured safety reports that summarize all available safety data for a medicinal product over a defined reporting interval. These reports are crucial for ongoing benefit–risk evaluation and regulatory compliance.

Based on the periodic analysis of worldwide safety reports, product label is updated to optimize safe use of a medicinal product.

Purpose of aggregate report writing

Summarize all Individual Case Safety Reports (ICSRs) and other safety data collected during a specific period.

Identify new safety signals or changes in the benefit–risk profile.

Provide regulators with an updated evaluation of the medicinal product’s safety.

1. Understand the purpose and regulatory basis of the DSUR – Explain the role of DSUR in providing an annual, comprehensive assessment of the safety profile of an investigational drug during its clinical development phase, as per ICH E2F guidelines.

2. Identify the required content and structure – Describe each section of the DSUR, including safety data summaries, benefit–risk evaluation, and emerging safety issues.

3. Apply data sources effectively – Recognize and integrate data from clinical trials, non-clinical studies, literature, spontaneous reports, and cumulative safety databases into the DSUR.

4. Interpret and present safety data – Develop skills to analyze adverse event trends, evaluate safety signals, and discuss significant changes in product safety knowledge over the reporting period.

5. Ensure compliance with timelines and submission requirements – Outline the regulatory submission timelines, target audiences (regulators, ethics committees), and confidentiality considerations.

6. Contribute to global safety oversight – Understand how DSUR findings influence risk management strategies, clinical trial conduct, and regulatory decision-making.

7. Understand the concept and regulatory requirement of PABRER – Explain its role as a periodic safety report that assesses the evolving benefit–risk profile of a marketed medicinal product.

8. Differentiate PABRER from other aggregate reports – Compare PABRER with PSUR, PBRER, and DSUR in terms of purpose, scope, and reporting timelines.

Learning objectives:

1. Will learn about the requirements mentioned in ICH E2C and E2F, good pharmacovigilance practices (GVP module VII), as well as global acceptability.

2. Source data collection, whole process of report preparation and critical aspects of writing, preparing line listings and summary tabulations.

3. In depth knowledge on template of DSUR, PBRER, RMP, CSR patient safety narrative and PADER.

Who will attend:

This course is intended for the professionals working within the pharmaceutical industry In pharmacovigilance, drug safety, regulatory, and medical writing positions. Professionals Most likely to benefit from this training are newcomers to the medical writing and/or Pharmacovigilance positions or writers/specialists with intermediate level of experience who Wish to extend their professional skills in aggregate reports.

Key Topics:

• DSUR: regulations, format and content of the document

• PBRER: regulations, format and content of the document

• PADAR: regulations, format and content of the document

• CSR patient safety narrative: Regulations, format and content of the document

• Six monthly clinical safety reports: Regulations, format and content of the document

Career opportunities:

1. As a fresher one can start their career in pharmacovigilance as drug safety associate/drug safety physician if you are a life science graduate or HCP. The role of Drug safety associates is mainly limited to ICSR processing.

2. With three years of experience you can be a part of signal management or aggregate writing/ PV medical safety writing teams.

3. For any team in pharmacovigilance process there will be two roles will be there one for other HCPs and one for Physicians.

4. With certification in pharmacovigilance and 5+ years of experience one can apply for management roles.

5. There are also other roles like QA and quality control teams, database admin in pharmacovigilance, based on interest and experience one can choose these positions.

What you’ll learn

• Development Safety Update Report (DSUR)

• Benefit-risk Evaluation Reports (PBRERs)

• Practice DSUR and PBRER

• Periodic Adverse Drug Experience Report (PADER)

• Risk Management Plan(RMP)

Are there any course requirements or prerequisites?

• Basic level of English

• Good quality of internet connection

• Desktop /Laptop/Smartphone required(Since dealing with online mode)

• Basic Knowledge on Pharmaceutical & medical field

Who this course is for:

• Graduate or postgraduate degree in Pharmacy or Pharmaceutical Sciences

• Graduate or postgraduate degree in Chemistry (subject) .

• Pharmacovigilance early experience candidates