Regulatory Information Management

Venue: Loews Philadelphia Hotel

Location: Philadelphia,, Pennsylvania, United States

Event Date/Time: Apr 24, 2012 End Date/Time: Apr 25, 2012
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Regulatory departments are continually being asked to do more with less. In addition, regulatory authorities are increasing the scrutiny related to patient safety and compliance with approved application information. As regulatory departments are challenged to develop global regulatory strategies, coupled with the corporate desire to launch in global markets early, the need to understand the regulatory requirements for filing, timelines, what products are approved in which markets is becoming a critical regulatory need for both industry and regulators. Effective regulatory information management processes and tools are needed to ensure the organization remains compliant with its product registrations.

This conference will feature a business focused track and a technology focused track. The Business Track will provide the opportunity to interact and share experiences related to processes for obtaining and managing regulatory information and the organizational impact. The Technology Track will focus on standards related to submission of regulatory information, the tools necessary to effectively manage the information, and associated implementation experiences and lessons learned.

Business Track
• Regulatory intelligence issues and challenges
• Managing RIM during mergers, acquisitions, and in- or out-licensing
• Management of correspondence and commitments
• Upcoming standards and potential impacts (EVMPD, RPS)
• Challenges with global information management
Tools and Technology Track
• Best Practices for management of regulatory activities using electronic tools
• Creating a business case for a RIM system
• Challenges for multi-national organizations with implementation of RIM tools
• Using RIM tools to achieve compliance
• Regulatory Intelligence – Using tools to aid business decisions
• Transitioning a business to a global RIM system

This program has been developed by the DIA Regulatory Affairs Special Interest Area Community (SIAC)

Learning Objectives:
At the conclusion of this conference, participants should be able to:
• Identify key business drivers for establishing a global regulatory information management system
• Share industry best practices related to standards and processes needed for effective regulatory information management
• Recognize the important role of regulatory intelligence in a regulatory information management strategy

Target Audience:
Professionals involved in:
• Clinical research & development/Clinical supplies
• eClinical
• Global project managers
• Information technology
• Regulatory affairs/operations
• Regulatory Information Management
• Regulatory, medical, and technical writers

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