Description
OVERVIEW
This course will offer insight into the compilation of the VNees, share experience and best practices gained during VNees submissions to SFDA.
Download Brochure Preparing VNeeS Submission 31 March, 2021 Riyadh
LEARNING OBJECTIVES
Every regulatory professional should have a solid understanding of the standards, groundwork, expertise and technology required to submit compliant VNees 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 VNees mandates.
At the conclusion of this course, participants will be able to:
- Participate in the preparation of the VNees including “submission ready documents”
- Recognize VNees requirements on a regional and ICH basis
- Create and submit technically valid GCC VNeess
- Prepare to move from a paper to VNees process
- Describe technology used for VNees compilation, validation and review
- Understand the difference between VNees and NeeS submission
- Have an overview on future eSubmission development
KEY TOPICS
- Overview of VNees readiness at the agencies
- Impact of the VNees on regulatory processes and procedures
- VNees compilation and life cycle management
- VNees 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
