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New York, NY

Masters program on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

The eCTD struggle is real. Regulatory submissions must conform to the electronic common technical document (eCTD) format to be successfully received and reviewed by health authorities. And while this might seem simple, this complex technical process is actually rife with risk if you lack expertise in medical writing and regulatory publishing. Every regulatory professional should have a solid understanding of the standards, groundwork, expertise and technology required to submit compliant eCTD submissions. This begins with understanding what will be accepted and what will not. Put yourself and your company a step ahead of competitors by understanding the technical skills and regulatory requirements necessary to meet the impending eCTD mandates. Why You Should Attend : This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD. Specific Topics: - Preparing your SOPs - Training authors - Selecting appropriate vendors - Submission project plan - Building the eCTD - FDA receipt and review process Program Features: 1. Online course delivery - Live instructor-led training delivered by top industry experts 2. Q&A after every session 3. Unlimited access to learning videos in case you miss the live classroom session 4. Soft copy of learning materials 5. Assessment at the end of the course; CCU certificate upon successful completion 6. Lifetime access to the learning platform with thousands of courses and 1-on-1 access to experts
  • Start:April 22, 2021
  • End:April 22, 2021
  • Recurring
  • Where:New York, New York, NY, USA,, New York County, New York, United States, 10018
  • Phone:N/A
  • Event Type: Other
  • Ticket Price:N/A
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