Overview
Primer Course: February 10
Short Courses: February 11
Forum: February 11-13
At the core of improving processes and building efficiencies is better organization and management of the data used in processes throughout the product lifecycle, an effort that can be complex and challenging under the best of circumstances.
DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum provides the elements needed to meet the challenges of optimizing the efficient use of regulatory information: the RIM principles, effective processes and tools, benefits to data applications across the product lifecycle, and examination of real-life results. 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.
Preconference Short Courses
February 10 | 10:00AM-5:00PM
Feburary 11 | 8:30AM-12:00PM
Featured
Short Course or Primer
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Feb 10, 2019
Primer: Regulatory Content and Submissions- Content from Authoring through Archive
Learn more -
Feb 11, 2019
Short Course 1: Blockchain Technology Education Course
Learn more -
Feb 11, 2019
Short Course 2: The Future of Regulatory Affairs
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)
- Examine the scope and assess the 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 -
Cindy Chiu • Senior Director, Regulatory Affairs Operations and Quality Management
Merck & Co., Inc., United States -
Venkatraman Balasubramanian, PhD, MBA • SVP and Global Head, Industry Solutions - Healthcare and Life Sciences
Orion Innovation, United States -
Ethan Chen, MBA, MS, PMP • Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
FDA, United States -
Jake Doran • Head of Digital
MAPS Public Benefit Corporation (MAPS PBC), United States -
Ron Fitzmartin, PhD, MBA • Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States -
Virginia Hussong • Chief, Data Standards Program, CBER
FDA, United States -
Joanne Malia, MS, MSc • Director, Development Records Management
Regeneron Pharmaceuticals, United States -
Karen McCarthy Schau • Director, Risk-based Study Management
Vertex Pharmaceuticals, 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 -
Norman Robert Schmuff, PhD • Associate Director for Science, OPMA, OPQ
FDA, United States -
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 -
Kevin Tompkins, MBA • Executive Director, Regulatory Information & Submission Management
Bristol Myers Squibb, United States
Contact us
Registration Questions?
Preconference Short Courses
Primer: Regulatory Content and Submissions- Content from Authoring through Archive
