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)
• Estimate 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