eCTD & CTD Preparation & Submission Course 2025

📚 Course Title: eCTD & CTD Preparation & Submission Course 2024 🚀

Headline: Master the Global electronic Submission, Review, and Lifecycle Management with our Comprehensive eCTD & CTD Preparation & Submission Course! 🌍📝

About the eCTD Specification: The eCTD specification has been developed to facilitate Global electronic Submission, Review, and Lifecycle management of medicinal product dossiers for regulatory applications. It's not just about submitting a static document; it's about creating a dynamic, updatable resource that evolves with the product throughout its lifecycle. 🛠️➡️🔄

Course Highlights:

• Lifetime Access: Learn at your own pace with lifetime access to the course materials. ✅
• Cost-Effective Learning: If you're paying more than ₹5,000 INR or $70 for a private institute/academy, you might be overpaying. We encourage you to compare and save with our course! 💰

Course Overview: This online course details the Electronic Common Technical Document (eCTD) specification. It provides guidance on the creation of an eCTD submission, discusses regional differences in dossiers, and is designed to adapt to the rapidly evolving requirements of electronic submissions. 📈

• Comprehensive Training: This class serves as a training and reference tool for anyone involved with electronic submissions. It's perfect for those new to the format and for seasoned professionals looking to stay current with the latest changes. 🔍

Learning Outcomes: Upon successful completion of this course, you will have a basic understanding of CTD & eCTD, and you'll be equipped to assist in compiling, filling out, and reviewing eCTD applications, particularly for EU and US requirements. 🎓

• Key Takeaways:
  • Basic Understanding of CTD & eCTD
  • Compiling eCTD Applications
  • Identifying EU & US Requirements
  • Transitioning from Paper-Based to eCTD Submissions
  • Reviewing eCTD Applications

Course Structure: The course is structured into 5 Modules, covering everything from an introduction and overview of CTD to lifecycle management for eCTD, with practical training on eCTD software for compilation and validation. 📚

• Module Breakdown:
  1. Introduction & Overview of CTD
  2. CTD Fundamentals ( Module 1 - 5)
  3. eCTD Fundamentals & Details
  4. Best Practice in Preparing eCTD
  5. Submission using eCTD Format
  6. Life Cycle Management for eCTD
  7. eCTD Software for Compilation & Validation

Who Will Benefit? This course is designed for professionals working in:

• QC/QA Managers & Staff
• Documentation Department
• Regulatory Affairs Departments
• Research Chemists, Quality Control Chemists, and CROs (Contract Research Organizations)
• Drug Inspectors/Controllers
• Drug Safety Specialists/Regulatory Food Safety Scientists
• Quality Operations/Quality Assurance Personnel 👥

Practical Training & Materials: Participants will be provided with course and study materials, receive practical training on eCTD, and have the opportunity to ask questions directly to the instructor during the course. 💡

Certification & Job Opportunities: Getting certified in this course opens up various job opportunities as:

• Regulatory Affairs Associates
• Regulatory Affairs Assistance
• Regulatory Affairs Heads/Directors
• Medical Information Associates
• And more! 🏢✨

Eligibility: This course is ideal for Life Science Graduates with experience or knowledge of Regulatory Affairs. 🎓

Join us to elevate your understanding and application of eCTD & CTD, and take a significant step forward in your career within the pharmaceutical industry! 🚀💼