February 8 - Tutorial (AM)*
February 8-10 - Forum
*Tutorials require registration and are an additional fee
EDM, ERS, and RIM have combined for the 2016 Regulatory Submissions, Information, and Document Management Forum. This forum will cover topics in four tracks: Electronic Regulatory Submissions (ERS), Regulatory Information Management (RIM) Business, RIM Technology, and Electronic Document Management (EDM).
In recent years, industry as a whole has been converging towards looking at regulatory as an end-to-end process. Document management, publishing, and technical regulatory requirements are all subsets of regulatory information management at its broadest definition. This course of managing documents starts at the creation of that document as part of the clinical trial. This conference serves as a forum for the discussion of emerging operational standards, best practices and the processes for submission, creation, and maximum use of regulatory information. The conference continues to explore information generated along the drug development continuum life cycle and alignment to ever evolving regulatory and electronic standards. The RIM business focused track provides the opportunity to interact and share experiences related to processes for obtaining and managing regulatory information and the organizational impact as well as gain a greater understanding of key issues shaping the global regulatory environment. The technology track will focus on standards related to submission of regulatory information, the tools necessary to effectively manage the information, and associated implementation experiences and lessons learned. The traditional ERS and EDM tracks will focus on emerging trends and best practices in regulatory submissions and electronic document management life cycle, respectively.
Lessons learned from recent mergers have highlighted the importance of regulatory intelligence as well as efficient systems and processes. Many people and companies define RIM differently, but maximizing access to information is critical to gain efficiencies and remain competitive. This year’s combined program aims to incorporate all relevant topics from the previous separate conferences without sacrificing focus.
As the Essential Documentation is created, reviewed, and approved via workflows and stored in electronic document repositories, the adoption of best practices and standards are critical to ensuring compliance and efficiency. As these repositories are subject to regulatory inspection, both at the Sponsor/CRO and the clinical site, practices of all stakeholders are transitioning to offer consistency while maintaining patient safety.
Experience the Forum on the Go with the DIA Global AppOnce you’re registered, use the DIA Global app to start preparing for the forum! Download the app to view the agenda and speakers, network with attendees and exhibitors, and get updates throughout the forum. Available for all Apple and Android products – just search “DIA Global” in your app store.
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Short Course or Primer
To keep you at the forefront.
Christian A. Buckley, MBA, RAC Associate Director, Regulatory Affairs
Astellas, United States
Betsy Fallen, RN Consultant
BAFallen Consulting LLC, United States
Sarah Powell, RAC President
Powell Regulatory Services, United States
Brooke Casselberry, MS, RAC Vice President, Engagement and Growth
Accumulus Synergy, United States
Michelle L. Charles, MPH Director, Regulatory Affairs, Gene Therapy Program
University of Pennsylvania, Perelman School of Medicine, United States
Jake Doran Head of Digital
MAPS Public Benefit Corporation (MAPS PBC), United States
Ron Fitzmartin, PhD, MBA Senior Informatics Advisor, Office of the Director, CBER
FDA, United States
Mark A. Gray Senior Project Manager, DSB, CBER
FDA, United States
Ginny Hussong Branch Chief, Data Standards, CBER
FDA, United States
Andrew Marr, PhD Managing Director
Marr Consultancy Ltd, United Kingdom
Thomas Noto Senior Director, Regulatory Operations
Lexicon Pharmaceuticals, United States
Daniel Orfe, MS President and CEO
Regulatory eSubmissions, LLC, United States
Michiel Stam Director Regulatory Information Management
Qdossier - A Celegence Company, Netherlands
Stacy Tegan Program Director
Transcelerate Biopharma, Inc., United States
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