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.

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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

Short Course or Primer

To keep you at the forefront.

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

Learn more

Feb 10, 2020

Short Course 2:

Preparing and Submitting Standardized Study Data to FDA, Presented by FDA, CDER

Learn more

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

Learn more

Feb 10, 2020

Short Course 2:

Preparing and Submitting Standardized Study Data to FDA, Presented by FDA, CDER

Learn more

Program Committee

Brooke Casselberry, MS, RAC Vice President, Consulting Services
Epista Life Sciences, 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
Lykos Therapeutics, United States
Ginny Hussong Branch Chief, Data Standards, 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, United Kingdom
Stacy Tegan Program Director
Transcelerate Biopharma, Inc., United States
Peter Terbeek, MBA Senior Director, Regulatory Operations
United States
Kevin Tompkins, MBA Executive Director, Regulatory Information & Submission Management
Bristol Myers Squibb, United States