About EDM and ERS/eCTD 2013

Integrating eDM, eSubs, and RIM
This year’s combined EDM and ERS/eCTD continues to explore information generated along the drug development continuum life cycle and alignment to ever evolving regulatory and electronic standards. The pace 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 generation, the complexities and challenges of data sharing and also data protection are becoming ever more apparent.  Advances in technology, standards, and evolving Regulations impact documents along their lifecycle.  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.

Who Should Attend

  • Regulatory Affairs and Operations
  • Global Submission Managers/Project Managers
  • Regulatory, Medical and Technical Writers
  • Data Managers
  • Information Technology and Support Personnel
  • Document and eRecords Managers
  • Regulatory Standards Implementation Specialists and Associates
  • Clinical Operations Representatives
  • Quality Assurance and Compliance Professionals
  • Contract Researchers and Service Support Providers
  • Emerging Pharmaceutical/Biotech/Device Professionals

Register Online


Group Discounts Available! Register 3 individuals from the same company and receive complimentary registration for a 4th.

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