Drug Safety Regulatory Requirements

This module provides information about pharmacovigilance harmonization initiatives and regulatory requirements around the world. It covers the key US and EU regulations, the roles that ICH and CIOMS play in drug safety regulations, good clinical and pharmacovigilance practices, and standard operating procedures (SOPs) that support drug safety.

The module takes an average of 4 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).

“Excellent module! Well organized and explained. I loved the interactive elements included to entertain and reinforce learning!”  

-Previous Participant

• Harmonization Initiatives
• Important US Regulations
• Important EU Regulations
• 2010 EU Legislation
• Global Safety Regulatory Resources
• Good Pharmacovigilance Practices: Documentation
• Standard Operating Procedures

This module is designed for professionals involved in:

• Drug safety and pharmacovigilance
• Clinical research and development
• Quality assurance and compliance
• Regulatory affairs
• Medical affairs
• Marketing

Upon completion of this module, learners should be able to:

• Identify key harmonization initiatives and important US and EU regulations
• Recognize the roles that the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and Council for International Organizations of Medical Sciences (CIOMS) play in drug safety regulations
• Describe good clinical and pharmacovigilance practices and standard operating procedures (SOPs) that support drug safety