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
