Drug Safety Regulatory Requirements eLearning Module
|
Course Badges
Drug Safety Regulatory Requirements
Keyword(s)
Drug safety, Pharmacovigilance, Good pharmacovigilance practices, Quality assurance, Compliance, Adverse events, Safety regulations
The Drug Safety Regulatory Requirements eLearning module provides information about pharmacovigilance harmonization initiatives and regulatory requirements around 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.
Credit Information
ACPE = 4
IACET = .4
IACET = .4
Description
Part of the DIA Drug Safety eLearning Program
The Drug Safety Regulatory Requirements eLearning module provides information about pharmacovigilance harmonization initiatives and regulatory requirements around 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.
Featured Topics:
- Harmonization initiatives
- Important US regulations
- Important EU regulations
- 2010 EU legislation
- Global safety regulatory resources
- Good pharmacovigilance practices: Documentation
- Standard operating procedures
Learning Objectives
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
- Define good clinical and pharmacovigilance practices and standard operating procedures (SOPs) that support drug safety
This module takes an average of 4 hours to complete.