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
- RMP Town Meeting
- Future Developments of RMPs and REMS
Register by September 9 and save $190.
DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org