Pharmacovigilence & Risk Management Strategies - USA 2012
conferencias > Biotechnology conferencias > Pharmacovigilence and Risk Management Strategies Meeting
January 23 - 25, 2012
Arlington VA , Estados Unidos
Title:
Pharmacovigilance and Risk Management Strategies 2012
Date(s) And Time(s):
Jan 23 2012 7:00AM - Jan 25 2012 4:00PM
Location:
Sheraton National Hotel Arlington
900 South Orme Street
Arlington, VA 22204
Interest Area(s):
Clinical Safety/Pharmacovigilance,Clinical Research,Regulatory Affairs,Research & Development,Statistics
Overview:
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
• Early Understanding of Clinical Safety and Risk
• Benefit-risk Analysis
• Social Media
• Biosimilars
• Data Sources and Observational Research
TUTORIALS
Four half-day preconference tutorials will address basic and introductory information on the following topics:
1. Signal Detection, Case Assessment and Data Mining
2. Development Safety Update Reports (DSURs)
3. Pharmacovigilance and Risk Management Planning
4. Optimization and Improving Operational Performance
Pharmacovigilance and Risk Management Strategies 2012
Date(s) And Time(s):
Jan 23 2012 7:00AM - Jan 25 2012 4:00PM
Location:
Sheraton National Hotel Arlington
900 South Orme Street
Arlington, VA 22204
Interest Area(s):
Clinical Safety/Pharmacovigilance,Clinical Research,Regulatory Affairs,Research & Development,Statistics
Overview:
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
• Early Understanding of Clinical Safety and Risk
• Benefit-risk Analysis
• Social Media
• Biosimilars
• Data Sources and Observational Research
TUTORIALS
Four half-day preconference tutorials will address basic and introductory information on the following topics:
1. Signal Detection, Case Assessment and Data Mining
2. Development Safety Update Reports (DSURs)
3. Pharmacovigilance and Risk Management Planning
4. Optimization and Improving Operational Performance
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