Preparing Compliant eCTD Submissions 2017 is a Workshop dedicated to
- Acronyms and words surrounding eCTD and electronic submissions
- Best practices with software used to generate electronic submission content
- A plan for transitioning your company into submitting in the eCTD format
- Technical requirements of the content of an eCTD submission
- EU submissions and procedures and how eCTD is different in the US and Europe
- ECTDs to minimize the chance of Refusal to Review and Refuse to File (RTF) actions by FDA
Who should Attend
Entry to mid-level regulatory professionals working in the biologics, drugs or combination products fields:
- Regulatory operations
- Medical writers
- IT staff
- Submissions publishing
