Over the past 20 years, the DIA EDM Conference has served as a platform for the discussion of emerging standards and processes for the creation, submission and retention of regulatory information. Within the past 2 to 3 years, there has been an increasing recognition of a broader and more complex environment that critically needs interoperability standards to create, electronically exchange and manage this ever growing array of medical and regulatory information. Being
Proactively positioned and strategically aligned will require internal thought and planning to facilitate process re-engineering and re-tooling.

While change is inevitable, the need for readily available current information while still ensuring data protection is essential. Traditional business roles are being remodeled and re-scoped with
The convergence of disciplines and cultural change. It is essential in this complex environment to not only continuously re-analyze the business and information process, but to analyze the impact
To touch points, intersections, interdependencies, and interoperability connectors all along the drug development continuum to ensure the delivery of safe and effective medical products.