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

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

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

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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