DIA will host Global Approach to the Risk Management of Medicines from September 30–October 1, 2010 in Washington, DC.
This conference will teach you how to identify and organize essential RMP components as they apply to medicinal products, therapeutic biologics, and vaccines. Global regulators, industry representatives, and Marketing Application Holders will explore:
- Why risk management plans (RMPs) are important to your organization from a global regulatory perspective
- Pros and cons of a global vs. local approach to developing RMPs
- How an harmonized RMP can promote efficient, evidence-based decision-making to support the best use of marketed products and thereby enhance public health
- How to develop an harmonized approach to creating an RMP
“Expert speakers will focus on well-described risks, poorly understood risks, and certain potential risks of products, which may be made available to patients and healthcare providers in different regions of the world,” explains Program Chairperson William W. Gregory, Director, Safety and Risk Management at Pfizer Inc.
Sessions will include:
- Risk Management Plans: What Do They Mean and What Are the Requirements for Each Region?
- Risk Management Plans: What Have We Learned from RMPs About Managing Product Risks?
- Panel Discussion: Regulators’ Perspectives
- Create Your Own RMP: Introduction to Practical Exercise
- Breakout Session: Develop Harmonized Risk Management Plan
- Group Report: Successes and Opportunities for Harmonized Risk Management Plans
- Future Developments of RMPs and REMS
Register by September 9 and save $190.
DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the life cycle management of pharmaceuticals, biotechnology, medical devices, and related products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.