Description

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

Regulatory Information Management 2014 brings together Directors, Senior Directors, Senior Managers, Associate Directors, Project Managers and Managers of: