Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada 2016 is a course that covers topics such as:
- IVD Regulations – U.S. FDA., Europe (MDD), Canada
- Why IVD is regulated differently
- Inclusion and exclusion of data and information for different submission
- Develop Regulatory Strategies and determine Regulatory Pathways
- Product Label and Labeling for IVDs
- Format and Content of premarket submissions
- Tips and Suggestions to secure rapid regulatory approvals
- Working and interacting with the reviewers and regulators
Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada 2016 brings together:
- Research & Development (R&D)
- Department Managers (middle management)
- Validation Engineering
- Product Design & Development
- Quality Assurance
- Regulatory Affairs
- Manufacturing/Production
- Quality Control
