Overview
This course provides the fundamental concepts of clinical safety. Learn how to comply with US Food and Drug Administration (FDA) and European regulations for clinical safety.
What You Will Learn
- Fundamental concepts of drug safety and pharmacovigilance and their application to clinical development
- How to comply with FDA and European regulations for clinical safety
- How to pass a preapproval safety inspection
- Proven concepts of premarketing risk assessment and its important role in the development of Risk Evaluation and Mitigation Strategies (REMS)
- How to effectively use signaling tools and techniques to support premarketing risk assessment
Who Should Attend
- Clinical safety and pharmacovigilance professionals
- Clinical development professionals
- Regulatory affairs professionals
- Quality management professionals
Learning Objectives
Participants who complete this course should be able to:
- Discuss why premarketing clinical safety and pharmacovigilance are important to ensure good pharmacovigilance practice
- Explain the requirements of FDA and European regulations for premarketing clinical safety and pharmacovigilance
- Prepare for a preapproval inspection for clinical safety
- Develop company policies and procedures for clinical safety
- Perform a premarketing risk assessment
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.