Adverse Drug Events - Understanding and Reporting Requirements

This two-day course is designed for those involved with Clinical Research, Safety Surveillance, Regulatory Affairs, Clinical Trials, Medical Affairs and QA/QC issues. It will also benefit Audit personnel and those in management who require a full understanding of adverse event reporting and regulations.

Learning Objectives

During this two day course you will learn about:

• FDA’s role in the drug development process
• The clinical research process
• Pharmacovigilance
• Adverse events (expected and unexpected)
• Safety issues
• Coding
• Safety issues in investigational studies
• Safety issues in the post-marketing era

Course Description

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

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COURSE AGENDA

DAY ONE

1. Introduction to FDA

• History
• Laws/Regulation/Guidelines/Policies

2. Definitions

• Clinical
• Safety

3. Introduction to ICH

• Purpose
• Why ICH
• Process

4. Overview of Pharmacovigilance

• Purpose
• Roles of FDA/ICH/CIOMS

5. Adverse Events

• What is it?
• Definitions
• Safety Reports

DAY TWO

6. Investigational Adverse Events

• Subjects
• GCPs
• IND Process

7. Marketed Products Adverse Events

• Domestic Reporting
• Other Report Sources

8. Data Management and Coding

• Coding
• 21CFR Part 11

9. Miscellaneous Issues

• SOPs
• Training
• Records

10. FDA Inspections

• Inspection Process