Regulatory Submissions, Information and Document Management Forum
Event details
Date: | February 10, 2020 - February 12, 2020 |
Website: | |
Location: | Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, North Bethesda MD, 20852, United States, America |
About
Blockchain Technology Life Sciences Regulatory Panel Discussion
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Listen in as expert speakers discuss potential healthcare use cases, real-world proofs of concept, and the benefits and risks associated with the application of blockchain.
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While we work on the agenda for 2020, check out our program from the 2019 event to see what’s in store.
Who should attend?
- 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
Learning objectives
- 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)
- Examine the scope and assess the 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