February 5: Short Courses
February 5-7: Forum
The Regulatory Submissions, Information, and Document Management Forum planning is underway! This Forum has experienced growth year after year in attendees, vendors, and presenters from industry and health authority representation, and 2018 is expected to continue this growth. Four tracks and daily health authority plenary sessions provide a comprehensive view of content and regulatory information management and submissions:
- 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.
All four 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.
This program is currently in development. Check out the Schedule At-A-Glance to see what's in store.
Preconference Short Courses on February 4-5
- Regulatory Content and Submissions Primer: Tracking Content from Conception to Interment | February 4
- This preconference training course is designed for individuals who are either new to biopharmaceutical-based document management, information management, and regulatory submission publishing for authorities, or already experienced in one area. Sign up for this course if you are looking to gain a broader understanding of the full spectrum of the regulatory submission, information, and document management arena.
- Global Identification of Medicinal Products: Applied Principles and Practical Benefits from Compliance and Beyond | February 5
- This Short Course is aimed at providing stakeholders with a foundational knowledge of IDMP to support practical implementation within their organizations. More specifically, it will address issues within the regulatory landscape and demonstrate applied strategies for the implementation of the ISO IDMP to support global medicinal product identification.
- Submission Survival Kit | February 5
- Walk through the important regulatory and clinical guidance documents, connecting them specifically to submission needs. This course will break down specific requirements by Module, including specific points on SPL creation and data packages, while noting best practices to avoid the dreaded RTF.
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
At the conclusion of this Forum, participants should be able to:
- Explain the regulatory electronic submission process from the completion of its upload to the Electronic System Gateway (ESG) through the time the submission is made available to the review team
- Discuss the agency target time frames for the 1) expected submission upload duration(s) and 2) timeframe between key milestones and notifications
- Describe the current required data standards for regulatory submissions and the status of ongoing data standards initiatives
- Describe organizational processes and governance to ensure integrity, quality, and security of regulatory information (data, documents, records)
- Envision the scope and future of data standards, including IDMP, with respect to systems, processes, and master data
- Discuss ways data can be harmonized, integrated, and viewed to provide an end-to-end view of the regulatory information value chain
- Discuss organizational implications related to increasing electronic interactions with stakeholders and health authorities
- Explain ways to improve processes and communication of regulatory activities including communications, end-to-end processes, and integration of systems for document, submission, and records management
- Interpret global health authority regulations and guidances for systems and business processes
- Identify ways in which the integration of data, documents, and knowledge can be leveraged to develop insights and enable better business decisions
- Identify changes in submission-related regulations impacting RIM business processes
Brooke Casselberry, MS, RAC • Owner
Cyan Life Sciences, United States
Michelle L. Charles, MPH • Director, Regulatory Affairs, Gene Therapy Program & Orphan Disease Center
University of Pennsylvania, Perelman School of Medicine, United States
Jamie Marie Toth, MS • Director/Head of TMF Operations
Daiichi Sankyo, Inc., United States
Venkatraman Balasubramanian, PhD, MBA • President and CEO
Cabeus, Inc., United States
Cindy Chiu • Director, Regulatory Affairs Operations & Quality Management
Merck & Co., Inc., United States
Jake Doran • Founder, Managing Director
List Innovations, LLC, United States
Betsy Fallen, RN • Consultant
BAFallen Consulting LLC, United States
Mark A. Gray • Senior Project Manager, BSS, CBER
FDA, United States
Virginia Hussong • Data Standards Program Manager, OD, BSS, CBER
FDA, United States
Thomas J. Noto • Sr. Director, Regulatory Operations
Daniel F. Orfe, MS • President & CEO
Regulatory eSubmissions, LLC, United States
Sarah Powell, RAC • President
Powell Regulatory Services, 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 • Director, Regulatory Affairs
Astellas, United States
Ron D. Fitzmartin, PhD, MBA • Senior Advisor, Office of Strategic Programs, CDER
FDA, United States
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