Short Courses: February 10
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.
- RIM Business track addresses processes for obtaining and managing regulatory information, organizational impact, and key issues shaping the global regulatory and business environments.
- RIM Technology track focuses on standards related to submission of regulatory information, tools to effectively manage the information, implementation experiences and results, and implications for refinement.
- Electronic Regulatory Submissions (ERS) track explores the submission process, regulatory requirements and new developments, best practices in regulatory submissions and industry adoption techniques.
- Electronic Document Management (EDM) track examines the processes, systems, and best practices for content management across the product lifecycle, including alignment with the RIM system for optimal use of regulatory information.
Key Takeaways from 2018 RSIDM
- Because the validated transactions of Blockchain are secure, documented, and unalterable and can involve currency, records, and many other types of information, this technology has great potential value for healthcare and pharma including drug supply chain, IDMP, and access to health records data.
- The FDA Technical Conformance Guide, updated each April and October, provides technical recommendations for the submission of animal and human study data in standardized electronic format in INDs, NDAs, ANDAs, and BLAs. The PDUFA VI Electronic Submissions and Data Standards Public Meeting will be held on March 21, 2018, to gather input from sponsors on the ESG, eCTD, IDMP, and ICSRs.
- FDA takes a positive view on the use of mobile technologies in health research because they enable the integration of research with healthcare delivery, presenting the potential for new endpoints and new ways to include all types of patients, including pediatric and cognitively impaired populations. Sponsors are encouraged to communicate with FDA before and during development efforts to help ensure that new endpoints are clinically relevant and that measurements are validated.
- Regulatory information has many uses outside of regulatory affairs, including safety reporting, supply chain, IDMP, and track and trace implementation. To begin exchanging data among existing data silos, interoperability on the technical, semantic, and organizational levels is required. When the “holy grail” of interoperability seems out of reach due to differences among data systems, smart workflow management systems can bridge disconnections.
The rich content of the plenary sessions and four tracks of the 2018 RSIDM Forum produced many key takeaways. While we prepare the agenda for 2019, check out the 2018 Program to see what was covered or download our exclusive eBook.
The Call for Abstracts for the 2019 RSIDM Forum will open in June! In the meantime, you may email Jessica.Roman@DIAglobal.org with any questions or suggestions for future topics.
Who should attend?
Professionals involved in:
- Regulatory Affairs and Operations
- Regulatory Information Management
- Global Submission/Project Management
- Medical, Technical, and Regulatory Writing
- Data Management
- Information Technology and Support
- Document and eRecords Management
- Essential Document Process and Business Systems
- Regulatory Standards Implementation
- Clinical Operations
- Quality Assurance and Compliance
- Contract Researchers and Service Support
- Emerging Pharmaceutical/Biotech/Device
- Vendor Relationship Management
Brooke Casselberry, MS, RAC • Owner
Cyan Life Sciences, United States
Michelle L. Charles, MPH • Director, Regulatory Affairs, Gene Therapy Program and Orphan Disease Center
University of Pennsylvania, Perelman School of Medicine, United States
Cindy Chiu • Director, Regulatory Affairs Operations and Quality Management
Merck & Co., Inc., United States
Venkatraman Balasubramanian, PhD, MBA • President and CEO
Cabeus, Inc., United States
Ethan Chen, MBA • Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
FDA, United States
Jake Doran • Chief Technology Officer
Genpact Pharmalink, United States
Ron D. Fitzmartin, DIAFellow, PhD, MBA • Senior Advisor, Office of Strategic Programs, CDER
FDA, United States
Virginia Hussong • Chief, Data Standards Program, CBER
FDA, United States
Joanne S. Malia, MS, MSc • Associate Director, Clinical Documentation Management
Regeneron Pharmaceuticals, United States
Thomas J. Noto • Senior Director, Regulatory Operations
Lexicon Pharmaceuticals, United States
Daniel F. Orfe, MS • President and CEO
Regulatory eSubmissions, LLC, United States
Sarah Powell, RAC • President
Powell Regulatory Services, United States
Karen Schau • Director, Consulting Services
CGI, United States
Norman Schmuff, PhD • Associate Director
FDA, United States
Vikesh Srivastava • Associate Director, Business Informatics Division, HPFB
Health Canada, Canada
Michiel Stam • Regulatory Information Scientist
eCTDconsultancy B.V., Netherlands
Stacy J. Tegan • Manager, Regulatory Technology Consulting
Accenture Accelerated R&D Services, United States
Peter Terbeek, MBA • Senior Director, Publishing and Submission
Astellas, United States
Kevin Tompkins, MBA, MS • Director, Head of North America, Global Submissions Management
Teva Pharmaceuticals, Inc, United States