3-hr Virtual Seminar: Introduction to the Electronic Common Technical Document

Why Should You Attend:

As standards continue to evolve, this introductory course is designed to provide life sciences professionals with a foundation in the fundamental concepts of the electronic Common Technical Document (eCTD) in order to facilitate awareness and understanding of the quickly evolving regulatory landscape.

This course provides a high level, practical approach to understanding the organization, structure, and technical aspects of the eCTD and highlights key considerations for submission management in terms of both individual submission preparation and lifecycle management over time.

Agenda:

• 10:00am PST to 11.30am PST Session 1.
• 11:30am PST to 11.45am PST Break.
• 11:45am PST to 1.15pm PST Session 2.

Learning Objectives:

• Review the process that led to the development of the CTD.
• Understand eCTD concept and structure.
• Become familiar with the underlying technology used in the eCTD.
• Understand how the eCTD organizes study files.
• Learn about lifecycle management advantages of the eCTD.
• Get a glimpse into the challenges and logistics of submission management.

Areas Covered in the Seminar:

• ICH Overview and Origins of CTD.
• CTD and eCTD.
  • Purpose.
  • Benefits.
• CTD/eCTD Structure.
  • Module Structure.
  • Authoring, Lifecycle Management, and Submission Type Considerations.
  • Basic Differences Between Paper and Electronic.
• eCTD: Technical Introduction.
• Preparing eSubmission ready documents to go in the eCTD.
  • File Naming.
  • Document Properties.
  • Open Settings.
  • PDF Version.
  • Bookmarks and Hyperlinks.
• Setting up the XML backbone to deliver the eCTD.
  • What is the XML backbone?
  • What file formats go in the eCTD?
  • Where do files go?
  • Introduction to Metadata.
• Study Tagging Files vs Node Extensions.

Who Will Benefit:

This workshop is designed for professionals from life sciences companies in:

• Medical Writing
• Regulatory Affairs
• Document Management
• IT Management
• Compliance
• Submission Management
• Professionals who are new to eCTD

Instructor Profile:

Lalana Dararutana, is a Principal Consultant in HighPoint Solutions’ Research and Development practice. With over 10 years of experience in the life sciences industry, Lalana is a seasoned professional with extensive experience across regulatory affairs and operations, including regulatory submission management, business process mapping for regulatory organizations, electronic publishing, eCTD best practices, change management, and document management systems.

Prior to joining HighPoint, Lalana worked both as a consultant, leading a broad range of projects providing regulatory consulting, business process analysis and submission content mapping for eCTD to ACTD applications, and in industry, holding senior regulatory affairs positions with ImClone, Valera Pharmaceuticals, Bristol-Myers Squibb, Kyowa Pharamceuticals, Sanofi, and DuPont.

Lalana is a RAC certified professional whose academic credentials include a Masters degree from Temple University School of Pharmacy’s graduate program in Quality Assurance/Regulatory Affairs and a Bachelor of Science in Biology from The College of New Jersey.

Follow us :