Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada 2016

Topics

• 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

Who should Attend

• Research & Development (R&D)
• Department Managers (middle management)
• Validation Engineering
• Product Design & Development
• Quality Assurance
• Regulatory Affairs
• Manufacturing/Production
• Quality Control