Adverse Events: Managing and Reporting for Pharmaceuticals

Upcoming Courses

Course #: SAEB0614
June 10-11, 2014
Metro Meeting Centers - Boston
Boston, MA
Take advantage of our $1,595.00 price by registering early!
* After May 9, costs are $1,795.00.

Course Description 

This course provides an excellent introduction for newcomers to the field of drug and biologic product AE reporting, a comprehensive overview of current approaches and regulations for professionals in the field, and challenging questions and ideas for the experienced safety information scientist. 

Learning Objectives 

  • Explain the purpose and capability of adverse event reporting 
  • Review and apply the concepts of seriousness, expectedness, and causality 
  • Review how to describe, characterize, and document adverse events 
  • Discuss safety issues and reporting obligations associated with clinical trials and marketed products including combination products 
  • Identify key concepts related to electronic records 
  • Discuss the use of various coding systems 
  • Describe the evolving role of the FDA in drug and biologics development 
Who Should Attend

  • Clinical Trial Personnel responsible for collecting, reviewing, and reporting investigational adverse events. 
  • Safety Surveillance Personnel responsible for the acquisition, classification, entry, analysis, and reporting of adverse events in marketed products. 
  • Regulatory Affairs Personnel responsible for submitting safety reports to FDA and international regulatory authorities. 
  • Quality Control Personnel involved in the investigation of adverse event reports 

This course contains medical device content related only to use in combination products. 


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

Jackie Stader, C.O.T., C.C.R.C. 

Click here for complete trainer biographies 

Course Outline 

Day 1: 8:30 a.m. – 5:00 p.m. 

  • Introduction to AE Management and Reporting: Brief history of the FDA; pertinent historical/ethical perspectives; overview of pharmacovigilance 
  • Clinical Trials: Overview of Regulations: FDA, ICH, EU, ISO; of concepts: causality, relatedness/expectedness, serious; sponsor reporting variations; FDA and international expedited reporting; post-marketing clinical trial considerations; reporting into IND; reporting into NDA; review of warning letters 
  • Use of Electronic Records and Coding Concepts: Electronic records: regulations, considerations in your environment, storage, submissions; MedDRA; SNOMED    

Day 2: 8:30 a.m. – 5:00 p.m. 

  • Post-Marketing: Overview of FDA and international regulations; FDA  and international reporting requirements; labeling requirements; product complaints/quality control; review 
  • Combination Products: Introduction to device regulations, definitions, concepts; overview of Office of Combination Products; reporting considerations for combination products 

Interactive Activities 

  • Routine Reporting in Clinical Trials 
  • Using MedWatch for 15-day Alerts 
  • Practice Using Coding Terminology 
  • Analysis of AE Reports on Combination Products 
  • Review of FDA Warning Letters 
  • Review and Evaluation of FDA Warning Letters in the Post-Marketing Setting 


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 

ACPE LogoBarnett 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 mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-13-027-L01-P. Released 9/13. 

Hold this course at your company! 

For more information, contact Naila Ganatra at (215) 413-2471. 


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On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
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Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

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