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Pharmacovigilance and Risk Management Strategies 2012

January 23-25, 2012 Tutorials: January 22, 2012
Sheraton National Hotel
Arlington, VA, USA

New Insights Into the Current Issues and Associated Challenges Impacting Drug Safety.

Top pharmaceutical, biotech, and regulatory representatives will discuss the current complexities and controversies in pharmacovigilance and risk management throughout all phases of development and marketed use, new and updated legislation in various ICH regions, important new harmonization initiatives, life cycle management, the impact of social media, biosimilars, and the use of other data sources and observational research. This program will focus primarily on drug products and biologics.

Featured Topics

Regulatory Day
New European, US, and Japanese Legislation
New Harmonization Initiatives
Risk Management/Life Cycle Management
Translating Pre-clinical Findings into Human Use
Benefit-risk Optimization
Social Media

Learning Objectives

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

Describe the latest regulatory framework for pharmacovigilance in the US, Europe, and Japan
Discuss new safety harmonization initiatives
Describe best practices for improving risk management and life cycle management approaches
Discuss how companies are using social media to investigate safety information in the context of regulatory obligations
Explain how to use other data sources and observational research for effective safety analysis

Who Should Attend

Professionals involved in:

Risk Management
Medical Product Safety Assessment
Regulatory Affairs
Clinical Research
Data Analysis
Quality Assurance/Quality Control
Medical Information

Event Information

Contact Ellen Diegel, Program Manager
Phone +215-293-5810, Fax +1.215.442.6199, email

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