Product/Service
Pharmacovigilance And Risk Management 2011
•Event Brochure: Pharmacovigilance And Risk Management 2011
Date(s) And Time(s):
Jan 9 2011 8:00AM - Jan 12 2011 5:00PM
Location:
Renaissance Washington, DC Hotel
999 9th Street NW
Washington, DC 20001-9000
Interest Area(s):
Clinical Research, Regulatory Affairs, Statistics, Public Policy/Law/Corp. Compliance, Quality Assurance/Quality Control, Research & Development
Overview:
Preconference Workshops
Several preconference workshops are being developed and will be offered on January 9, 2011. Monitor www.diahome.org for information as it becomes available.
Conference Overview
Clinical trial safety and postmarketing pharmacovigilance is more critical than ever in the development and evaluation of the safe use of marketed medical products. This comprehensive three-day program will discuss the current complexities and controversies in pharmacovigilance and risk management throughout all phases of development and marketed use, how to optimally utilize epidemiological, clinical pharmacological and other techniques, risk management strategies, and how to create an effective organizational "system." This program will focus primarily on drug products and biologics, but medical devices will have a limited role in the discussions.
Featured Topics
- Latest international regulatory developments
- Generating and assessing critical safety data during development
- Compliance with clinical safety and postmarketing pharmacovigilance regulatory requirements in an evolving global environment
- Recent multinational initiatives under the International Conference on Harmonization (ICH) and Council for International Organizations of Medical Sciences (CIOMS) on Drug Safety Update Reports (DSURs) in premarketing clinical trial safety
- New approaches in risk management, risk communication, labeling and packaging to optimize medical product benefit while minimizing preventable harm
Learning Objectives:
At the conclusion of this meeting, participants should be able to:
- Discuss the latest regulatory frameworks for pharmacovigilance in the US, Europe, Japan, Asia/Pacific Rim, China, Central America and South America
- Explain new views on periodic safety reporting during clinical development as proposed by the CIOMS VII Working Group and the ICH E2F Expert Working Group
- Identify best practices for quality assurance in postmarketing pharmacovigilance and clinical safety
- Review current FDA, EMEA, EU, MHLW and ICH risk management approaches
- Discuss the impact of public health actions and health professional education on medical product safety
- Recognize why shared responsibility among multiple stakeholders (including government, industry, health professionals and consumers) is essential for effective medical product risk management and minimization
Target Audience:
Professionals with at least basic knowledge of, and experience in, clinical safety and who are involved in:
- Pharmacovigilance
- Clinical research
- Regulatory affairs
- Risk management
- Medical product safety assessment
- Data analysis
- Epidemiology
- Labeling
- Quality assurance/control
- Compliance
- Medical information
•Event Brochure: Pharmacovigilance And Risk Management 2011
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