Overview

The Drug Safety Regulatory Requirements eLearning module provides a global overview of pharmacovigilance harmonization initiatives and regulatory requirements. It covers key U.S. and EU regulations, the roles of ICH and CIOMS in shaping drug safety standards, and the application of good clinical and pharmacovigilance practices, along with the SOPs that support them.

The module takes an average of 2.75 hours to complete.

This eLearning module can be purchased individually or as part of the Drug Safety eLearning Program(6 modules) or Drug Safety eLearning Bundle (7 modules).

Featured topics

- Harmonization initiatives
- Important US regulations
- Important EU regulations
- 2010 EU legislation
- Global safety regulatory resources
- Pharmacovigilance Documentation Practices
- Standard operating procedures

Who should attend?

This module is designed for professionals involved in:
- Clinical safety and pharmacovigilance
- Clinical research
- Quality assurance and compliance
- Regulatory affairs
- Medical affairs
- Marketing

Learning objectives

Upon completion of this module, learners should be able to:
- Differentiate between key harmonization initiatives and important US, EU and other regional regulations
- Recognize the roles of major organizations and authorities involved in drug safety, including ICH, CIOMS, FDA, and EMA
- Identify requirements introduced by the EU pharmacovigilance reform
- Recognize good clinical and pharmacovigilance practices and standard operating procedures that support drug safety

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Drug Safety Regulatory Requirements

Overview

Featured topics

Who should attend?

Learning objectives

Be informed and stay engaged.