Drug Information Association Logo

Introduction to Drug Safety

| Online

« Back to Listing

Overview 

This module is part of the DIA Drug Safety eLearning Program. The Introduction to Drug Safety course provides a foundation of knowledge required to work day-to-day in clinical safety and pharmacovigilance.  This module will also benefit individuals who wish to complete the Drug Safety eLearning program.

This module provides information on the legal basis for safety reporting, including a historical perspective; basic definitions and tools; the mechanics of drug safety and pharmacovigilance; reference safety information provided by the Investigator’s Brochure and postmarketing labeling; and evaluation of seriousness, expectedness, and causality.

Featured Topics 

  • Drug Safety: The Basics
  • Terminology
  • A “Typical” Company Safety Unit
  • Tracking a Case from Start to Finish
  • Assessing Cases
  • Reference Safety Information: The Investigator Brochure and Postmarketing Labeling

Who Should Attend 

Professionals working in the area of:

  • Clinical safety & pharmacovigilance
  • Clinical research
  • Regulatory affairs
  • Medical writing
  • Marketing

Learning Objectives 

Upon completion of this course, participants should be able to:

  • Discuss the history, principles, and regulatory framework for clinical drug safety
  • Define terms used in day-to-day pharmacovigilance work
  • Describe a typical company drug safety unit and the path of a case from start to finish
  • Explain reference safety information provided by the Investigator Brochure and postmarketing labeling
  • Explain the assessment of seriousness, expectedness, and causality of adverse events

Special Offers 

Buy all six modules and Save 20%!

Contact Information 

Linda Belmont, DIA
Phone +1.215.293.5818
Linda.Belmont@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Continuing Education 

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The Drug Information Association designates this educational activity for up to 4.0 contact hours or .4 CEUs. 0286-0000-14-411-H04-P Type of Activity: Application


Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .4 CEUs for this program.

This eLearning module is part of DIA’s Certificate Program and is awarded the following: • Clinical Safety and Pharmacovigilance Certificate Program: 2 Elective Units
If you successfully complete all six modules in the Drug Safety eLearning Program, the Elective Units will be converted into the required Core Units in the Clinical Safety and Pharmacovigilance Certificate Program. For more information go to www.diahome.org/certificateprograms

Release Date: May 7, 2014
Expiration Date: May 7, 2017*

*Continuing education credit is available to participants who successfully complete the eLearning program before the expiration date.

Name Credit Type Max Credits CEU
Introduction to Drug Safety ACPE 4.00 0.400
Introduction to Drug Safety IACET 4.00 0.400

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

In order to receive a statement of credit (before the one year purchase expiration date and before the expiration date listed above), please review the entire module, complete the exam and evaluation form. You must receive a passing score of 80% or better to receive a statement of credit. A statement of credit will be emailed within one month of receipt of exam and evaluation form. Please note: If you do not complete the module, pass the module exam, AND complete the evaluation form, you will not receive a statement of credit.

Registration Fees 

Other Fees

Individual
$400.00
Group Discounts

When purchasing modules from the DIA Drug Safety eLearning Program:

  • Purchase 2-5 modules and receive a 10% discount on each item
  • Purchase 6 modules and receive a 20% discount on each item

Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

« Back to Listing Back To Top