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
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Program Committee
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Brooke Casselberry, MS, RAC Vice President, Advisory and Delivery
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 -
Venkatraman Balasubramanian, PhD, MBA Healthcare and Life Sciences Strategic Advisor
VB Insights, LLC, United States -
Ethan Chen, MBA, MS, PMP Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
FDA, United States -
Jake Doran Vice President, Digital
Lykos Therapeutics, United States -
Ron Fitzmartin, PhD, MBA Senior Advisor, Office of Regulatory Operations, CBER
FDA, 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 -
Sarah Powell, RAC President
Powell Regulatory Services, United States -
Norman Schmuff, PhD Associate Director for Science, OPMA, OPQ, CDER
FDA, United States -
Michiel Stam Management Consultant
MAIN5 Gmbh & Co. Kgaa, Germany -
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
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