4th eRegulatory Submissions Summit 2020

Topics

• Regulatory Perspective: Explore How to All Be on the Same Page, Including Vendors
• Strategic Planning for Submitting Master Files and Commercial Investigational New Drug Applications in eCTD Format
• EMA Announced the New Location, November 20, 2017, Netherlands — Explore the Impact of the Industry in Light of This Announcement
• RIM/Records Management: Building Key RIM Partnerships and Changes in Records Policy
• ANDA, CMC Criterion: Discuss Some of the Enhancements of CMC Filling Requirements in ANDA

Who should Attend

• Regulatory Writing/Medical Writing/Publishing/Information/Submissions
• Regulatory Affairs
• IDMP
• Document and eRecords Management
• Labeling
• Business Operations/Processing
• Clinical Data
• Clinical Trials Management/Data
• Product Development
• Outsourcing/Clinical Outsourcing/Vendor Management
• Quality Assurance/Quality Control