Regulatory Information Management 2014

Regulatory Information Management 2014 is focused on

• Validation of off the shelf vendor solutions
• Personal and company views on system validation
• Meeting the auditors expectations on system validations
• Customisation of vendor solutions and implications for validation
• Integrating other department systems and the implication for validation
• Experiences of agency validation requirements and expectations
• Advice from vendors on system validation
• Is system validation a balance and where is the tipping point?
• Differentiating between system and data validation
• Validating RIM solutions with a global reach
• What are your next RIM project plans?
• What technology drivers will change RIM in the future?
• What do you want to see from vendors and service providers?
• What operational difficulties do you still have to overcome?
• Which regulations will have the greatest impact on RIM?
• What is on your RIM "wish list"?
• Which departments do you plan to integrate within your RIM project?
• RIM as a basis for operational excellence in regulatory operations
• What will RIM look like in 5 years? Evaluating the various meanings and interpretations of RIM
• How will pharma restructuring affect RIM?
• Discussing established RIM models, options and their suitability for difference company types
• Outlining when and why RIM projects may be required by your company
• Integrating other departments and systems in RIM projects
• Highlighting essential considerations for evaluating company needs and requirements
• Appreciating company technical environments, IT structures, infrastructures and their impact on RIM projects
• Highlighting data ownership and responsibilities in RIM
• Considering legacy products and data when planning RIM projects
• Assessing how your products and data influence your RIM
• Assessing business benefit, ROI and commercial viability for new RIM projects
• Estimating the resources required for planning, implementing and maintaining RIM
• Essential advice for assessing vendors and tools providers
• Considering future developments and their impact on RIM
• Considering ISO when developing plans for RIM
• What are your next steps towards more effective Regulatory Information Management?
• Addressing the demands of external information exchanges with health authorities on RIM

Who should Attend

Directors, Senior Directors, Senior Managers, Associate Directors, Project Managers and Managers of:

• Submissions
• Regulatory Operations
• Document Management
• Publishing
• Central IS/IT Teams
• Regulatory IS
• Regulatory Systems
• Regulatory IT
• Documentation & Information Services
• Regulatory Information
• Pharmacovigilance