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
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
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
Brooke Casselberry, MS, RAC • Associate Vice President, US Life Sciences Advisory and Consulting
NNIT, Inc., 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 • Senior Vice President and Global Head, 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 Global R&D IT
Bausch Health, United States
Betsy Fallen, RN • Consultant
BAFallen Consulting LLC, United States
Mark A. Gray • Senior Project Manager, DSS, 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 • Head of Data Management and Regulatory Information Scientist
Stacy Tegan • Associate Director, Program Management
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
Download our Guide!
Preconference Short Courses