Perspectiva general
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.
Register today!
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.
Register today!
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 GUIDEHow 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 InfographicPreconference Short Courses on February 4-5
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Comité del programa
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Brooke Casselberry, MS, RAC Vice President, Advisory and Delivery
Epista Life Sciences, 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 Healthcare and Life Sciences Strategic Advisor
VB Insights, LLC, United States -
Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
Merck & Co., Inc., United States -
Jake Doran Vice President, Digital
Lykos Therapeutics, 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 Management Consultant
MAIN5 Gmbh & Co. Kgaa, Germany -
Stacy Tegan Program Director
Transcelerate Biopharma, Inc., United States -
Peter Terbeek, MBA Senior Director, Regulatory Operations
United States -
Ron Fitzmartin, PhD, MBA Senior Advisor, Office of Regulatory Operations, CBER
FDA, United States
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