DIA is proud to present the Regulatory Submissions, Information, and Document Management Forum. This forum was initially three separate DIA meetings: EDM (Electronic Document Management), ERS (Electronic Regulatory Submissions), and RIM (Regulatory Information Management), each with their own unique histories. In 2015, those three meetings were combined into one forum in an effort to represent the end-to-end process of managing regulatory submissions and documents. The response to this approach has been incredibly positive with record attendance in 2016, as it serves as the premier place for the discussion of emerging operational standards, best practices, and the processes for submission, creation, and maximum use of regulatory information. The forum continues to explore information generated along the drug development continuum life cycle and alignment to ever evolving regulatory and electronic standards.
Meet us at the event
Amplexor Life Sciences Suite is an INTEGRAL next-generation solution for management of enterprise regulated content and processes as well as publishing. Achieve and maintain global regulatory compliance - meet our consultants at the event to learn how!
To schedule your meeting, please contact:
Eric Haase (T: +1 585 880 2590, E: eric.haase@amplexor.com).
Featured topics
- Electronic Document Management
- Electronic Regulatory Submissions
- Regulatory Information Management for Businesses
- Regulatory Information Technical Management
- Identification of Medicinal Products (IDMP)
- Structured Authoring
- eTrial Master File
Learning objectives
At the conclusion of this forum, participants should be able to:
- Describe organizational processes and governance to ensure integrity, quality, and security of records
- Discuss how to break down silos for end-to-end processing of regulatory information as it relates to EDM and ERS
- Envision the scope and future of IDMP with respect to systems, process, standards, and master data
- Discuss organizational implications related to increasing electronic interactions with stakeholders
- Explain ways to implement processes to improve communication of regulatory expectations and communications
- Interpret global health authority regulations and guidances for systems and processes
- Describe how to map eTMF capabilities to support clinical site inspections
- Identify techniques to create efficiencies in the overall end-to-end process of document and submission management
Venue
Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road, North Bethesda
MD 20852, USA