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Pharmacovigilance and Risk Management Strategies 2012 |
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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
REMS
Translating Pre-clinical Findings into Human Use
Benefit-risk Optimization
Social Media
Pharmacoepidemiology
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:
Pharmacovigilance
Risk Management
Medical Product Safety Assessment
Regulatory Affairs
Clinical Research
Data Analysis
Pharmacoepidemiology
Labeling
Quality Assurance/Quality Control
Compliance
Medical Information
Event Information
Contact Ellen Diegel, Program Manager
Phone +215-293-5810, Fax +1.215.442.6199, email Ellen.Diegel@diahome.org |
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