Overview
February 9: Primer
February 10: Short Courses
February 10-12: Forum
Regulatory information is arguably the most valuable asset of a pharmaceutical, biotech, or medical device company. It includes data, meta-data, documents and other forms of information about regulatory and submission intelligence, regulatory authority submission and reporting requirements, submission plans for new products and life cycle management activities, as well as product registration information, labeling, CMC, and safety submissions, communications from health authorities, and more
How regulatory information is managed has a profound impact on operational efficiency across the whole organization, on data quality, and ultimately on the company’s ability to meet the needs of patients. As global regulatory requirements, technology, data sources, and data standards evolve, the importance of sound regulatory information management becomes even greater.
DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum brings together industry and regulatory stakeholders working across the scope of regulatory information to examine current data standards and requirements and effective regulatory information management approaches to align related systems. The Forum presents four tracks: Regulatory Information Management (RIM) Business, RIM Technology, Electronic Document Management, and Electronic Regulatory Submissions. Cross-track sessions provide the opportunity to discuss key connection points across major components of regulatory information, and plenary sessions featuring regulatory intelligence updates by FDA and other regulatory authorities are offered each day.
The program has been released! Preview all session descriptions, speakers, and more all in one place!
View Program.
This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees.
Featured
Short Course or Primer
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Feb 09, 2020
Regulatory Content and Submission Primer: Content from Authoring to Archive
Learn more -
Feb 10, 2020
Short Course 1: Data at the Heart of Life Science Professionals: Instant Informed Decision-Making
Learn more -
Feb 10, 2020
Short Course 2: Preparing and Submitting Standardized Study Data to FDA, Presented by FDA, CDER
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 -
Ron Fitzmartin, PhD, MBA • Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States -
Venkatraman Balasubramanian, PhD, MBA • SVP and Global Head, Industry Solutions - Healthcare and Life Sciences
Orion Innovation, United States -
Danielle Beaulieu, PhD • Senior Director, Global Regulatory Business Capabilities
Bristol-Myers Squibb, 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 -
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 -
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
Regulatory Content and Submission Primer: Content from Authoring to Archive
Short Course 1: Data at the Heart of Life Science Professionals: Instant Informed Decision Making
Short Course 2: Preparing and Submitting Standardized Study Data to FDA
Additional Information
Regulatory Affairs and Submissions Resource Kit
