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!
This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees.
Want to learn more about Regulatory Submissions, Information, and Document Management Forum? You've come to the right site!
Short Course or Primer
To keep you at the forefront.
Brooke Casselberry, MS, RAC Vice President, Engagement and Growth
Accumulus Synergy, 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 the Director, 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
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, 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
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