European Drug Safety and Pharmacovigilance Compliance - Webinar by GlobalCompliancePanel
19 Oct 2010
Webinar
This webinar will describe European PV requirements, including compliance with applicable laws, regulations and guidance. In addition, attendees will learn how to compare the company`s PV operations to applicable best practices in Europe.
Why should you attend: Large and small pharmaceutical companies face an increasingly complex set of international regulations in their commitment to patient safety and Good Pharmacovigilance Practices. The regulatory framework in Europe presents complex challenges to meeting international requirements effectively.
Areas Covered in the Session:
International Conference on Harmonization (ICH)
Regulatory Framework
European Medicines Evaluation Agency (EMEA)
Eudravigilance
Electronic submission of ICSRs
EVWEB
EUDRA CT Database
EU clinical trials directive
SUSARs
Periodic reporting
Clinical trial safety reporting
UK clinical trial regulations
Eudralex Volume 10
Eudralex Volume 9A
Typical Clinical Safety Process Model
Best Practice Approach to Clinical Safety
Achieving Best Practices through the Pharmacovigilance Audit
Required Company Documentation
Clinical Safety Case Study
Pharmacovigilance Risk Profile
Pharmacovigilance Concepts
Example of an Effective Supporting Information Architecture
Example of How Signaling Supports Good Pharmacovigilance Practice
Signaling Fundamentals
The Pharmacovigilance Audit
Who Will Benefit:
Clinical Safety/Pharmacovigilance
Regulatory Affairs
Quality management
Clinical research & development
Past Events
European Drug Safety and Pharmacovigilance Compliance - Webinar by GlobalCompliancePanel - 19 Oct 2010, Webinar (8537)
European Drug Safety and Pharmacovigilance Compliance - Webinar by GlobalCompliancePanel 2026
Important
Please, check "European Drug Safety and Pharmacovigilance Compliance - Webinar by GlobalCompliancePanel" official website for possible changes, before making any traveling arrangements
