September 22-24 2014
Omni Shoreham Hotel
Following the success of last year’s combined EDM and ERS/eCTD event, EDM 2014 continues to explore evolving global trends in e-records, systems and e-context in the Clinical and Regulatory space. The rapid evolution of global electronic initiatives necessitates industry to continually assess internal processes to maximize content reuse and streamline efforts by pushing submission-ready and data standards farther upstream. As technologies and standards progress along with the real-time increasing volume of information, business paradigm has shifted many companies to investigate outsourcing solutions to remain competitive. Managing the associated risk, transparency, reliability and accessible document storage are essential elements for ensuring your organization’s compliance to current and emerging regulatory requirements.
To keep up with the changes in technology, advanced skill sets have become increasingly critical for personnel in the regulatory submissions and e-records space. In addition to their core skills, professionals in this field need to possess qualities like adaptability and business management skills as well as a high aptitude for learning multiple Information Technology (IT) systems and vendor management. To be successful in this fast-paced environment, it is critical to embrace change management and focus on continual improvement in both processes and professional development.