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.

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Overview

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

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

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.

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

    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.

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    Student Testimonials

    • Suma D
      with a background of B.Pharm in India, worked as a clinical pharmacist for four years before moving to the US and joined Sollers. She has completed the Advanced Drug Safety and Pharmacovigilance certification program in 2016. After two years of a career break, she has done a certificate program from Sollers. Sollers College has prepared her to offer as a drug safety associate in Bioclinica even after a two-year career gap. Now she is pursuing an MS program in DSP.
      Suma D
    • Suman B
      With a Ph.D. in Pharmaceutical Sciences background, Suman B worked as a drug safety associate in India. He pursued the ADSP course in Feb 2020. Sollers College has inspired him to move one step forward and try new things and help him leave that comfort zone. He got placed as a safety data associate within six months before the start of the internship.
      Suman B
    • Rebecca J
      Foreign Medical doctor, Singapore, completed a diploma in family medicine in 2008, worked as a physician before moving to the US in 2015, joined Sollers for the ADSP program in Jan 2019. Under the guidance of professors, he grasped the knowledge of Career growth in the Healthcare sector. Soller College has inspired him to go the extra mile and try new experiences outside his comfort zone. After certification, he was settled as a Regulatory Post Marketing Safety Specialist for a medical device company.
      Rebecca J
    • Viraj P,
      with a background of Pharm D, worked as a pharmacist and Pharmacy Manager. He joined the Advanced drug Safety program in 2019. Sollers provides a host of real-world opportunities for him. He was involved in working on real-time case scenarios. Sollers supported him by giving interview tips and resume preparation. After completing the certification, he is working in his interesting zone with a PV clinical associate position.
      Viraj P,

    Campus Visit