概要
February 3-5: 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. Our Forum brings a set of tracks and focus areas, equipping our attendees with invaluable insights on how to build and sustain successful RSIDM foundations, optimize their current processes and procedures, adopt innovative technologies, and achieve regulatory excellence. This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees at all levels.
While we develop our 2025 Agenda, please take a moment to review our 2024 FINAL PROGRAM!
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, CBER, 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.
Featured
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プログラム委員会
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Jillian E. Carinci, MS Senior Director, Head of Submission Sciences
Biogen, United States -
Cary Smithson, MBA Senior Director, Business Transformation & Systems Management
Cencora Pharmalex, United States -
Sandra Krogulski, MA Director, GRSO Innovation and Business Operations Lead
Bristol-Myers Squibb Company, United States -
Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
Merck & Co., Inc., United States -
Jonathan Resnick, PMP Project Management Officer, OBI, OSP, CDER
FDA, United States -
Rita Algorri, PhD, MS Senior Manager, Global Regulatory Affairs (CMC)
Amgen, United States -
Jennifer Dames Director, RA Submission Management
Abbvie, United States -
Lindsey Fitzgerald Senior Consultant
Astrix, United States -
Dominik Gigli Management Consultant
Main5 GmbH & Co. KGaA, Germany -
Shenqi (Handsome) Ji Regional Publishing Lead, Asia, Global Regulatory Operations
Pfizer, China -
Jared Lantzy, PMP Executive Director, Global Regulatory Operations
Novavax, Inc., United States -
Teresa Martins Senior Director, US Site Head Regulatory Submission Management
Bayer U.S. LLC, United States -
Sarah Pope Miksinski, PhD Executive Director, CMC Regulatory Affairs
Gilead Sciences, United States -
Aliza Nathoo Senior Business Transformation Leader
F. Hoffmann-La Roche Ltd., Canada -
Daniel Offringa Principal Consultant
eSub Solutions, United States -
Nimesh Patel Director of Global Regulatory Systems & Operations
Eisai Pharmaceuticals, United States -
Noelia Plaza Director of Process Excellence & Analytics
Daiichi Sankyo, United States -
Maria Sagoua, MHA Director of Regulatory Innovation
Accumulus Synergy, United States -
Seyoum Senay, MS Supervisory Operations Research Analyst, CDER/OBI
FDA, United States -
Matthias Sijtstra Senior Data Management Specialist
Celegence Netherlands, Netherlands -
Representative Invited DIA, United States
