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 the compilation of safety data for a drug over a prolonged period (months or years). The periodic reports play an important role in risk-benefit evaluation of the drug and involves 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

Syllabus

Register now, to get the complete syllabus.



    Instructors

    Our instructors are not just highly experienced in the industry, they give you the personal attention you need and guide you every step of the way.

    Shaurya Chandel

    Faculty of Drug Safety and Pharmacovigilance, Oracle Argus


    Course Duration

    Starting soon

    Reserve your spot

    Engagement

    45 hours

    For information regarding fee and/or reserving your spot, contact our Admissions Team.

    Credit transfers applicable for alumni

    OUR STUDENTS WORK AT

    Sollers partners with industry-leading corporations and provides them with ready-on-day-one employees. We record an 82% placement rate within three months of graduation.

    Financial Options

    Sollers has devised viable financial options for you to ensure tuition does not get in the way of your education. Now, you can focus your attention where it needs to be – in the classroom!

    Career Guidance

    After the completion of program, we assist our students with interview coaching, resume building sessions, conduct mock interviews, job readiness training and make them competent to venture into the corporate world.

    We provide exclusive one-on-one sessions with our industry-based career advisors who provide guidance right from resume feedback, assisting with interview Q&As, and helping with job preparations.

    Student Testimonials

    • Emmanet T.
      The Clinical Trial Management course is extensive, and the professors are thorough in delivering the course materials using real life experience and insight. Career Services helped me throughout the interview process, and I landed my dream job with the very first interview after graduating from Sollers.
      Emmanet T.
    • Rudolf M.
      Thanks to the academic team at Sollers, I was able to gain quick admission with financial options to pay tuition. Career Services was very helpful with resume and interview prep. They sent me job postings with major hospitals and pharma companies which helped me land my current job as Data Manager in cancer clinical trials.
      Rudolf M.
    • Sampada Lokhande
      “Sollers has great certificate and internship programs in Clinical Trials domain. I have recently completed Clinical Data Science program with Sollers. Their faculty, facilitators, career services all are knowledgeable and experienced in the field of Clinical Trial. I was very happy with the internship program too. They provided me with valuable guidance throughout my program, internship and job application process. I definitely would recommend Sollers.edu to anyone who wants to pursue education in Clinical Trial industry 👍🏼”
      Sampada Lokhande

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