Drug Safety Aggregate Reporting

Learn to create reports in the world’s most relied-upon aggregate reporting formats and provide a broader view of the safety profile of a drug.

Overview

Why Aggregate Reporting

Aggregate reporting involves compiling safety data for a drug over a prolonged period (months or years). The periodic reports play an essential role in the risk-benefit evaluation of the drug and involve collective analysis of cases in the database, monitoring regulatory actions, literature searches, etc.

In This Course

Learn how to create Periodic Safety Update Reports – now known as the Periodic Benefit-Risk Evaluation Report, Preapproval Reports including IND Annual Reports and Annual Safety Reports, and Post-approval Periodic Adverse Experience Reports.

The Sollers Advantage

The Aggregate Reporting short-term program by Sollers is taught by faculty experienced in the industry. The program is a great way to quickly develop the in-demand skills working with the aggregate reporting methodologies and gaining valuable hands-on experience.

Learning Outcomes

  • The procedure to generate line listings
  • Summarize tabulation of ADR cases in Oracle Argus Safety Database
  • Content and preparation of the reports
  • Country specific requirements
  • Guidelines governing periodic reports

Highlights

For Hands-on Training in Aggregate Reporting:

We are enhancing our Argus Internship Sessions by incorporating hands-on training in Aggregate Reporting and believe that the knowledge and training that the students gain will enhance the scope for better opportunities in the drug safety and PV industry.

There will be 4 to 5 sessions of hands-on Aggregate Reporting training conducted on Saturdays from 10 am to 2 pm EST. The number of students per session will be limited and the number of students will be determined on a First Come, First Serve basis, strictly.

Course Duration

Starting Soon

Reserve your spot

Engagement

45 hours

Get In Touch:

admissions@sollers.edu

or

Call Us Via:

73280 67846

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