The 4th eRegulatory Submissions Summit 2020 covers topics such as:
- 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
The 4th eRegulatory Submissions Summit 2020 brings together:
- 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