February 5: Short Courses
February 5-7: Forum
At the Regulatory Submissions, Information, and Document Management Forum, DIA will present four tracks and daily health authority plenary sessions to provide a comprehensive view of content and regulatory information management and submissions. All tracks are supported with daily plenary sessions providing regulatory intelligence updates by health authority representatives from FDA, Health Canada, and other regions of interest.
This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business- and technology-focused attendees. Tracks include:
- RIM Business track addresses processes for obtaining and managing regulatory information, organizational impact, and key issues shaping the global regulatory and business environments.
- RIM Technology track focuses on standards related to submission of regulatory information, tools to effectively manage the information, implementation experiences and results, and implications for refinement.
- Electronic Regulatory Submissions (ERS) track explores the submission process, regulatory requirements and new developments, best practices in regulatory submissions and industry adoption techniques.
- Electronic Document Management (EDM) track examines the processes, systems, and best practices for content management across the product lifecycle, including alignment with the RIM system for optimal use of regulatory information.
TWO On-Demand Webinars
EDM and ERS - Hot Topics and Tools of the Trade
This webinar will address current hot topics impacting EDM and ERS. A high-level overview of the various tools and process’s which are required for the effective and efficient operation of an organizations quality regulated content and document/submission publishing.
Enterprise Ontology Approach to System Implementation and Process Development to Minimize Organizational Disruption
This webinar will explore how these methods, based on the work by Professor Jan Dietz, can be used to facilitate the implementation of system changes in various use cases in the biopharmaceutical industry.
Why Attend the Regulatory Submissions, Information, and Document Management Forum?
Download DIA's exclusive Regulatory Submissions, Information, and Document Management Forum Resource Guide to stay up-to-date in the regulatory field (including eSubmissions, EDM, ERS, and IDMP), gain Short Course information, trending key topics, and the top reasons why you can't afford to miss this forum!DOWNLOAD GUIDE
How Will the RSIDM Forum Address Key Regulatory Changes?
Check out our infographic on Forum highlights and the top reasons why you must be in attendance.View Infographic
Preconference Short Courses on February 4-5
Want to learn more about Regulatory Submissions, Information, and Document Management Forum? You've come to the right site!
Short Course or Primer
To keep you at the forefront.
Feb 05, 2018
Essentials for Compiling/Publishing Compliant Electronic Submissions (eCTDs)
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
Jamie Toth, MS Global Head, TMF Management & Records
Beigene, United States
Venkatraman Balasubramanian, PhD, MBA SVP and Global Head, Industry Solutions - Healthcare and Life Sciences
Orion Innovation, United States
Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
Merck & Co., Inc., United States
Jake Doran Head of Digital
MAPS Public Benefit Corporation (MAPS PBC), United States
Betsy Fallen, RN Consultant
BAFallen Consulting LLC, United States
Mark A. Gray Senior Project Manager, DSB, CBER
FDA, United States
Ginny Hussong Branch Chief, Data Standards, CBER
FDA, United States
Thomas Noto Senior Director, Regulatory Operations
Lexicon Pharmaceuticals, United States
Daniel Orfe, MS President and CEO
Regulatory eSubmissions, LLC, United States
Sarah Powell, RAC President
Powell Regulatory Services, United States
Vikesh Srivastava Associate Director, Business Informatics Division, HPFB
Health Canada, Canada
Michiel Stam Director Regulatory Information Management
Qdossier - A Celegence Company, Netherlands
Stacy Tegan Program Director
Transcelerate Biopharma, Inc., United States
Peter Terbeek, MBA Senior Director, Regulatory Operations
Astellas, United States
Ron Fitzmartin, PhD, MBA Senior Informatics Advisor, Office of the Director, CBER
FDA, United States
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