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Barnett International's Core Curriculum courses are comprehensive role-based training programs designed to provide participants with hands-on training in a dynamic setting. Held four times a year during Barnett’s “Clinical Research Training Weeks,” courses offer focused, performance-based training and employee development.

Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance

Upcoming Courses

Course #: SSVB0622
June 1-2, 2022 | VIRTUAL

This course offering will take place live via WebEx from 9:00 AM – 4:00 PM Eastern each day.  Participants will receive an email confirmation that includes the seminar link to enter the meeting room as well as the audio connection information.


Course Description

This course covers the fundamentals of drug safety and pharmacovigilance, including regulatory requirements, adverse event reporting, signaling and risk management. The course addresses the regulatory issues across U.S. and EU agencies that improve safety, but slow down the product approval process. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence, and regulatory compliance. This course will provide learners with regulatory references, processes, best practices, and analysis and investigation techniques to minimize risk, avoid product recall, and meet U.S. and EU safety reporting standards.

Learning Objectives

  • Describe regulatory requirements for product safety
  • Signal detection, risk assessment and management functions
  • Define how to collect, assess, report, and analyze adverse events
  • Demonstrate the importance of good adverse event data collection in identifying signals
  • Signaling analyses based on FDA Good Pharmacovigilance Practices
  • Introduce FDA Good Pharmacovigilance Practices and EMA Good Pharmacovigilance (GVP) Modules and their relevance to Aggregate Reporting, Risk Management, and Signal Detection
  • Identify differences between U.S. and European regulatory requirements

Who Should Attend

  • Drug Safety and Pharmacovigilance Professionals
  • Regulatory Affairs Professionals
  • Senior Level Executives
  • Clinical Development Staff


The course will be led by one of the following instructors:

Sharon Donatucci

Click here for complete trainer biographies

Course Outline

Day One

  • What is Pharmacovigilance?: Definition and history; corporate pharmacovigilance; ADR system; critical elements
  • What is an Adverse Event Drug Reaction?: Adverse Drug Reaction definition; sources of SADRs; types of ADRs; ADR reports to FDA/EMEA; serious ADR; unlabeled or unexpected ADR; expectedness “listed” vs. “unlisted”; severity/intensity; lack of efficacy; pharmacovigilance
  • Global Regulatory References and Expectations: Global regulations addressing safety (ICH, CIOMS, FDA and EU)
  • Regulatory Reporting: Expedited reporting timelines; aggregate reports and timelines

Day Two

  • PV Audits and Audit Issues: Regulatory inspections; preparation, problems and issues; checklists; ADR; inspection principles; inspection results; potential regulatory actions
  • Signaling: What is safety signal; safety signal generation; definition; pharmacovigilance process; risk/benefit; situations for signal detection; sources of signals; analysis and investigation of a signal; understanding safety signals; suspected signals, risk assessment
  • Characteristics of a Good Case Report: How to do a narrative evaluation for follow-up; active query; investigator's brochure; safety; interim update for investigators; FDA time/report obligations; regulatory reporting and notification
  • Risk Management: Understanding Risk Evaluation and Mitigation Strategy (REMS) and Risk Management Plans (RMP)

    Interactive Activities

  • Case Study Reviews
  • Exercises in Drug Safety concepts

    Registration Fees

    Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

    Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.    

    Click here for our seminar cancellation policy

    Accreditation Information

    Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours 1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-21-033-L04-P. Released: 10/21.

    Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.