Webinar: at $130 its an expensive one!!

Webinar: at $130 its an expensive one!!

Title:
How Pharmacovigilance Audits Can Ensure Regulatory Compliance

Date(s) And Time(s):
Mar 26 2008 10:00AM - Mar 26 2008 11:30AM

Interest Area(s):
Clinical Safety/Pharmacovigilance, Clinical Research and Development, RA/Policy/Drug or Device Approval/GRP, Pharmacoepidemiology/QoL/HealthEcon/OutR, R&D/Strategic Issues

Overview:

Large and small pharmaceutical companies face an increasingly complex set of international regulations in their commitment to patient safety and Good Pharmacovigilance Practices. The specialized operational configurations of firms present complex challenges to meeting international requirements effectively. Pharmacovigilance audits can contribute to regulatory compliance and support industry best practices.



FEATURED TOPICS

Learn how a pharmacovigilance audit:

· Captures the requirements of all applicable regulatory bodies;

· Reviews company practices across the product lifecycle;

· Inspects detailed documentation on case processing and decisions made;

· Evaluates related information systems; and

· Documents successes, failures and improvements.



Learning Objectives:

At the conclusion of this webinar, participants should be able to:

· Discuss why the pharmacovigilance audit is important to ensure Good Pharmacovigilance Practice;

· Explain the impact of FDA regulations on international safety reporting and review methods; and

· Describe the objects and components of a pharmacovigilance audit.



Target Audience:

Professionals involved in:

· Clinical Safety/Pharmacovigilance

· Pharmacoepidemiology

· Regulatory affairs

· Quality assurance

· Medical product safety assessment

· Labeling

· Clinical research



Event Code:
08211

Contact Information:

For information about this and other upcoming webinars, contact Jessica Kusma at DIA.

Tel +1-215-442-6182 - Fax +1-215-442-6199

email Jessica.Kusma@diahome.org


Webinar