EDM and ERS 2014
September 22 - 24, 2014 - Washington
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. This conference serves as a forum for the discussion of emerging standards and the processes for submission creation and maximum use of regulatory information. Once again facilitated roundtable lunch discussions will be offered on industry hot topics as well as the “Ask the Regulators Session” to provide a venue to discuss hot topics with the Regulators and ask the panelists questions regarding FDA submission standards, processes, regulations, guidance, or initiatives (questions can be submitted ahead of time).