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34594 Conferences

European Drug Safety and Pharmacovigilance Compliance - Webinar by GlobalCompliancePanel

Added by davidross759 on 2010-09-02

Conference Dates:

Start Date Start Date: 2010-10-19
Last Date Last Day: 2010-10-19

Conference Contact Info:

Contact Person Contact Person: Manzoor
Email Email:
Address Address: Online Training Webinar, Online, DE, 19801, United States
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

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
* EUDRA CT Database
* EU clinical trials directive
* 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
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