概览

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.

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.

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谁应该参加？

Forum Designed For
- Clinical Data/Data Managers
- Clinical Operations and Processes
- Contract Research and Service Support Providers
- Document and Records Management/Specialists
- Emerging Pharmaceutical/Biotech/Device Professionals
- Essential Document Process and Business System Owners
- Informatics/Bioinformatics Professionals
- Information Technology and Support Personnel
- Medical, Technical, and Regulatory Writers
- Outsourcing/Clinical Outsourcing
- Quality Assurance/Quality Control and Compliance Professionals
- Quality Management
- Regulatory Affairs and Operations
- Regulatory Informatics
- Regulatory Information Management
- Regulatory Standards Implementation Specialists and Associates
- Strategic Planning and Operations
- Submissions and Global Submissions Management/Project Management
- TMF and eTMF Management
- Vendor Relationship Managers

学习目标

At the completion of this conference, the participant should be able to:
- Recognize key components and define essential practices necessary for building and sustaining effective RSIDM systems that align with current regulatory requirements and global standards
- Explain methodologies for enhancing operational efficiency within RSIDM processes, and illustrate practical applications of process optimization techniques that foster continuous improvement and regulatory compliance
- Apply knowledge of emerging technologies, including AI and automation, to regulatory information management challenges, and demonstrate how these innovations can enhance data quality and submission efficiency
- Analyze the impact of global standards, such as eCTD and IDMP, on regulatory submissions, and differentiate between regional regulatory requirements to effectively navigate international compliance challenges
- Synthesize insights from case studies and expert discussions to create actionable strategies for achieving regulatory excellence within an organization, emphasizing leadership, decision-making, and process transformation
- Evaluate the importance of cross-functional collaboration in regulatory affairs, and appraise approaches to fostering interdepartmental communication, aligning regulatory submissions with organizational goals, and enhancing overall submission success

项目委员会

Jillian E. Carinci, MS Senior Director, Head of Submission Sciences
Biogen, United States
Cary Smithson, MBA Managing Partner
LeapAhead Solutions, Inc., 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
Kunal Lal, MBA Consultant - Strategy & Change
Red Nucleus, United Kingdom
Aliza Nathoo Senior Director, Content Strategy
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
Vladimir Penkrat, MBA Head of Regulatory Affairs
Indegene, United States
Noelia Plaza Director of Process Excellence & Analytics
Daiichi Sankyo, United States
Theresa Pinnell, MLS Director of Regulatory Solutions
Kivo, United States
Maria Johnette Barhams 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 Consultant
Main5 GmbH & Co. KGaA, Netherlands
Representative Invited DIA, United States