Industries: Pharma / Biotech

Adverse Drug Events- Reporting & Regulatory Requirements

Course Director: Michael A. Pierro

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

This course will provide participants with an understanding of drug safety at the investigational stage and during the marketing phase. Adverse event identification and reporting requirements will be addressed, as well as FDA, EMA, Health Canada and ICH roles in the drug safety process. The course will also discuss international law/regulations, ICH guidelines, Pharmacovigilance, definitions and current regulatory issues.

Adverse Event reporting requirements specific to the US, Canada, Japan, and Europe will be discussed and compared in detail. Participants will be provided with templates for reporting requirements in each region covered.

Multiple exercises are included to reinforce the lecture material. Through the use of various scenarios, participants will learn how to assess and report AEs including SAEs.

Who Should Attend

This two-day adverse drug events training course is designed for those working in the clinical research, safety surveillance, regulatory affairs, medical affairs, QA/QC, and any others who would benefit from a complete understanding of international regulations regarding monitoring and reporting adverse events.

Course Agenda

First Day

09:00 – 09:30 Welcome & Agenda Review

09:30 – 10:45 AE Terminology

  • Definitions & classification of key terms
  • Exercise 1 – Module 1

10:45 – 11:00 BREAK

11:00 – 12:00 AE Regulatory Environment

  • Regulatory requirements similarities and differences:
    • Canada
    • EU
    • Japan
    • US

12:30 – 01:00 LUNCH

01:30 – 02:00 AE Regulatory Environment (continued)

  • Exercise 2 – Module 2

02:00 – 03:00 Post-Marketing AE Reporting

  • FDA & ICH Compliance Programs
    • Program Objectives
    • Inspections
    • Administrative action
    • Minimum reporting criteria
    • Key data elements for reporting
    • Blinded studies

03:00 – 03:15 BREAK

03:15 – 04:00 Post-Marketing AE Reporting

  • FDA & ICH Compliance Programs
  • Exercise 3 – Module 3
  • Exercise 4 : AE Scenarios

04:00 – 04:30 Recap and Q&A

Second Day

09:00 – 10:00 ICH Requirements for Clinical Safety Data Management & Reporting

  • Background
  • General reporting principals
  • Sources of reportable information
  • Describing AEs
  • PSUR & Summary Bridging Reports
  • Standards for non-serious AE reporting
  • Exercise 5-Module 4

10:00 – 10:15 BREAK

10:15 – 11:00 Pharmacovigilance

  • Risk management
  • Signal detection
  • Safety specification
  • Pharmacovigilance methods
  • Active surveillance
  • Passive surveillance
  • Exercise 6 – Module 5
  • Exercise 7 : Completion of of SAE Report Form

11:00 – 12:00 Workshop

  • Develop a PVP

12:00 – 01:00 LUNCH

01:00 – 02:00 Workshop continued

02:00 – 02:30 Reference Summary/Review

02:30 – 02:45 BREAK

02:45 – 03:15 Recap and Q&A Issues

Learning Objectives

During this two day course you will learn about:

  • Adverse Event (AE) Terminology
  • Role & responsibilities of Pharma and the Regulatory Agency in AE reporting
  • Pre & Post-marketing AE reporting requirements worldwide
  • Product Safety Update Reports
  • Pharmacovigilance
  • Safety issues
  • Coding
  • The new Final Rule requirements for reporting SARs/SUSARs
  • The differences in reporting requirements between the US and EU


"The course and materials are very informative. The Course Director's pace and discussion of the course allowed me to ask questions and retain the overall material. It was a pleasure having him as the instructor." Nu T., Regulatory Affairs Associate, G & W Laboratories
"The course director did a great job covering a lot of necessary information while making it applicable and interesting. He has a broad knowledge base, but was still very willing to have others share experiences to enhance the course. This was a great investment of my time!" Diane C., Clinical Specialist, MED Institute
"Lots of good materials and discussions. The course was very interactive and complete." David U., Dir. Clinical Development, Medicines for Malaria Venture - Geneva
"Very informative - gained valuable understanding of ADE reporting history." Susan W., Sr. Product Support Specialist, Pfizer
"I like the Course Director's process of having exercises after each module to review the basic topics covered in that module. He also easily refers back to the regulations when questions are asked. I highly recommend this course...the best Adverse Events training available!" Marissa F., Manager, Vasogen
"I highly recommend this class to anyone who is involved in clinical research and operation in the investigator sites and sponsor sites, as well as health professionals. Thank you so much and I am looking forward to taking other classes you offer in the future!" Ge Z., MD, PhD, Manager of Clinical Development, Siemens Medical Solutions USA
"This was a wonderful course - I thoroughly enjoyed the instructor!" Felisa P., Clinical Data Manager, BioMimetics

Frequently Asked Questions

Does this course discuss the differences in reporting requirements between US and EU?

Yes, this course discusses the similarities and differences in Adverse Event reporting requirements between the US, EU, Canada and all ICH regions.

Is the role of the QP covered?

Yes, the role of the QP is covered in detail with respect to Pharmacovigilance activities and GMP responsibilities.

Does this course discuss product complaints?

This course discusses product complaints and how they might impact product safety and adverse events.