Overview
Short Course: February 9, 2023 | Virtual
Short Course: February 10, 2023 | Virtual
Primer: February 12, 2023 | In-Person
February 13-15: Forum
The last few years have shed light on the importance of operational efficiency of the management of regulatory information to ensure quality regulatory submission to health authorities. We have seen how the ability to perform at this level has allowed drug companies to bring therapeutics and vaccines to patients faster. At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum, we will hear from industry and regulatory stakeholders working across the scope of regulatory information to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related people, processes, and technology. The Forum presents four tracks: Regulatory Informatics Business, Regulatory Informatics Technology, Trial Master File (TMF) Inspection Readiness and 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.
This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees.
Participant Testimonials
The forum was incredibly valuable in terms of meeting colleagues from around the world —industry and regulators — and collaborating on solutions to improve submission efficiency andmake data more readily usable. – Virginia Hussong, Chief Data Standards Program, CBDER, FDA
Fantastic forum! I am 17 years in the pharmaceutical industry, but new to the regulatory sector, and it was great to align my prior manufacturing knowledge to the regulatory area. Great event! All the right people, all in the right place! – Matthew Tyler, Director of Business Development, Qdossier, a Celegence Company
The breadth of subject matter expertise, and diverse perspectives make RSIDM a must attend event for anyone involved in Regulatory activities. – Gary Colantonio, MS, MBA, Associate Director, Regulatory Affairs, Merck & Co., Inc.
Need Approval in Order to Attend?
Download and fill out our Justification Letter to demand to supervisor why this is a must-attend event.
Keynote Address!
February 13 | 1:25-2:00PM
Ulo Palm, MD, PhD, MBA Chief Medical Officer Vaxxinity
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Program Committee
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Michiel Stam Director Regulatory Information Management
Qdossier - A Celegence Company, United Kingdom -
Karen McCarthy Schau Director, Risk-based Study Management
Vertex Pharmaceuticals, United States -
Stacy Tegan Program Director
Transcelerate Biopharma, Inc., 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 -
Jo English VP and General Manager, Enterprise Technology
Calyx, United Kingdom -
Vahe Ghahraman, PhD Senior Director, Global Regulatory Operations Head
Apellis Pharmaceuticals, Inc. , United States -
Kristen Sauter, MBA Senior Director, Head, Global RIM, Analytics & Digital Innovation
Takeda Pharmaceuticals, United States -
Cary Smithson, MBA Senior Director, Business Transformation & Systems Management
Cencora Pharmalex, United States -
Katherine Novak, MS Principal Product Manager
Accumulus Synergy, United States -
Alison Buno, MBA Senior Director, Regulatory Submissions
AbbVie, Inc., United States -
Joanne Malia, MS, MSc Director, Development Records Management
Regeneron Pharmaceuticals, United States -
Jamie O'Keefe Head, Clinical & Regulatory Consulting
Astrix, United States -
Joel Finkle Industry Expert
Retired, United States -
Sandra Krogulski, MA Director, GRSO Innovation and Business Operations Lead
Bristol-Myers Squibb Company, United States -
Rob Labriola, MS Exec. Director, Regulatory Operations
Garuda Therapeutics, United States -
Daniel Offringa Principal Consultant
eSub Solutions, United States -
Jonathan Resnick, PMP Project Management Officer, OBI, OSP, CDER
FDA, United States -
Representative Invited DIA, United States
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