Overview
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
Featured
Short Course or Primer
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Feb 05, 2018
Course 1: Global Identification of Medicinal Products: Applied Principles and Practical Benefits from Compliance and Beyond
Learn more -
Feb 05, 2018
Course 2: Essentials for Compiling/Publishing Compliant Electronic Submissions (eCTDs)
Learn more -
Feb 04, 2018
Regulatory Content and Submissions Primer: Tracking Content from Conception to Interment
Learn more
Who should attend?
Professionals involved in:
- Regulatory Affairs and Operations
- Regulatory Information Management
- Global Submission/Project Management
- Medical, Technical, and Regulatory Writing
- Data Management
- Information Technology and Support
- Document and eRecords Management
- Essential Document Process and Business Systems
- Regulatory Standards Implementation
- Clinical Operations
- Quality Assurance and Compliance
- Contract Researchers and Service Support
- Emerging Pharmaceutical/Biotech/Device
- Vendor Relationship Management
Learning objectives
At the conclusion of this Forum, participants should be able to:
- Explain the regulatory electronic submission process from the completion of its upload to the Electronic System Gateway (ESG) through the time the submission is made available to the review team
- Discuss the agency target time frames for the 1) expected submission upload duration(s) and 2) timeframe between key milestones and notifications
- Describe the current required data standards for regulatory submissions and the status of ongoing data standards initiatives
- Describe organizational processes and governance to ensure integrity, quality, and security of regulatory information (data, documents, records)
- Estimate the scope and future of data standards, including IDMP, with respect to systems, processes, and master data
- Discuss ways data can be harmonized, integrated, and viewed to provide an end-to-end view of the regulatory information value chain
- Discuss organizational implications related to increasing electronic interactions with stakeholders and health authorities
- Explain ways to improve processes and communication of regulatory activities including communications, end-to-end processes, and integration of systems for document, submission, and records management
- Interpret global health authority regulations and guidances for systems and business processes
- Identify ways in which the integration of data, documents, and knowledge can be leveraged to develop insights and enable better business decisions
- Identify changes in submission-related regulations impacting RIM business processes
Program Committee
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Brooke Casselberry, MS, RAC • Associate Vice President
NNIT, 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 -
Virginia Hussong • Chief, Data Standards Program, 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 Regulatory Operations, CBER
FDA, United States
Contact us
Registration Questions?
On-Demand Webinars
EDM and ERS - Hot Topics and Tools of the Trade
Download our Guide!
Regulatory Submissions, Information, and Document Management Forum Resource Guide
Preconference Short Courses
Regulatory Content and Submissions Primer: Tracking Content from Conception to Interment
Essentials for Compiling/Publishing Compliant Electronic Submissions (eCTDs)
