Description
OVERVIEW
This course will offer insight into the compilation of the eCTDs, share experience and best practices gained during eCTD submissions in the GCC, explain the eCTD review and lifecycle process and the upcoming eCTD requirements.
LEARNING OBJECTIVES
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.
At the conclusion of this course, participants will be able to:
- Participate in the preparation of the eCTD including “submission ready documents”
- Recognize eCTD requirements on a regional and ICH basis
- Create and submit technically valid GCC eCTDs
- Prepare to move from a paper to eCTD process
- Describe technology used for eCTD compilation, validation and review
- Understand the difference between eCTD and NeeS submission
- Have an overview on future eSubmission development
KEY TOPICS
- Overview of eCTD readiness at the agencies
- Impact of the eCTD on regulatory processes and procedures
- Practical experience of submitting an eCTD in the GCC
- eCTD compilation and life cycle management
- eCTD Validation
- Document granularity and readiness
- Technical issues
- Specifications and standards
WHO WILL ATTEND
Professionals working in:
- Pharma Regulatory Affairs
- Scientific Office Managers
- Regulatory Authorities.
- Dossier Management
- Pharmacist
- Compliance
- Submission Management/Electronic Publishing
- Data Management / IT
