Welcome! This blog is designed to be an open forum for Regulatory people from life sciences companies to share information, ask questions, and get answers on Electronic Regulatory Submission topics.
Some of the topics to be discussed include:
- Regional updates, Module 1, guidance documents, requirements, etc.
- Electronic submission technologies (eCTD 4.0/RPS)
- Electronic document formats and data
- Expanding types of electronic submissions
- Current and emerging standards of impacting electronic submissions
- Best practices (bookmarking/linking, granularity, templates, validation, study tagging files, lifecycle considerations, when to talk to HAs, etc.)
- IDMP
- RIM
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