About Sollers

Sollers is a graduate school located in New Jersey, specializing in clinical research, drug safety and pharmacovigilance training.

Our graduate certificate and masters programs cover a wide range of subjects tailored to this fast growing industry, and our graduates go on to highly successful careers in the pharmaceuticals industry and healthcare industries.

  • HOURS
  • Monday - Thursday | 10 AM - 7 PM
  • Friday | 12 PM - Midnight
  • Saturday | 12 PM - Midnight
  • Sunday | Closed
  • OPEN 24/7 - sollers.edu
    • PHONE
    • (848) 299-5900
    • Location
    • 100 Menlo Park, Suite 550
      Edison New Jersey 08837 -2488

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Sollers Blog

Aggregate Reporting in Drug Safety and Pharmacovigilance

Posted by Doctor Dan on Jun 15, 2017 3:30:33 PM

Over view of the program - Cumulative –or- Aggregate reporting, also known as Periodic Reporting, plays a key role in the safety assessment of drugs. Aggregate reporting involves the compilation of safety data for a drug over a prolonged period of time (months or years), as opposed to single-case reporting which, by definition, involves only individual AE reports. The periodic reports plays 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. They are required to be submitted to various regulatory agencies to comply with the regulatory requirements. The advantage of aggregate reporting is that it provides a broader view of the safety profile of a drug.

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Topics: Aggregate Reporting in DSP