Preparing Compliant eCTD Submissions 2017

  • 2017
  • Rockville, MD, United States

Description

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

Preparing Compliant eCTD Submissions 2017 brings together entry to mid-level regulatory professionals working in the biologics, drugs or combination products fields:

  • Regulatory operations
  • Medical writers
  • IT staff
  • Submissions publishing

Past Events

Important

Please, check "Preparing Compliant eCTD Submissions" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Legal
Government & Global Issues: Law & Regulations
Health & Medicine: Pharma
Science: Life Sciences & Biology

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