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EVENT DATE
Apr 2015
M T W T F S S
13141516171819
EXPO DATE
Apr 2015
M T W T F S S
13141516171819

Venue

Courtyard Newark Downtown 858 Broad Street
Newark , NJ 07102
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Type: Indoor - Hotel

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Navigating through Maze of In-vitro Diagnostics (IVD) Regulations

Courtyard Newark Downtown
B2B 30

EVENT DESCRIPTION

Course Description:

In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices, they are regulated under a separate set of regulations in U.S., Europe, and Canada.

This 2 day interactive course on in-vitro diagnostics is structured to understand the different set of IVD regulations, how to navigate through this maze of IVD regulations, and to win regulatory approvals. This In-vitro Diagnostics (IVD ) course will make the attendees understand the IVD regulations and develop regulatory strategies that secure regulatory approvals.

Learning Objectives:

After completion of this two day interactive course on IVD, the attendee will be able to:

  • Understand why IVD is regulated differently.
  • An overview of IVD Regulations – U.S. FDA., Europe (MDD), Canada.
  • Develop Regulatory Strategies and determine Regulatory Pathways.
  • Inclusion and exclusion of data and information for different submission.
  • Format and Content of premarket submissions.
  • Product Label and Labeling for IVDs.
  • Working and interacting with the reviewers and regulators.
  • Tips and Suggestions to secure rapid regulatory approvals.

For Registrationhttp://www.complianceonline.com/in-vitro-diagnostics-ivd-regulatory-approvals-in-us-europe-canada-seminar-training-80148SEM-prdsm?channel=eventsinamerica

Note: Use coupon code 232082 and get 10% off on registration.

Contact the event managers listed below for more information about how you can participate at the Navigating through Maze of In-vitro Diagnostics (IVD) Regulations.

EVENT CONTACTS

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EVENT DETAILS

Primary Industry:
Medical Technology
Other Industries:
Manufacturing, Medical, Medical Technology, Professional Healthcare
Audience:
Department Managers (middle management)
Research & Development (R&D)
Product Design & Development
Validation Engineering
Regulatory Affairs
Quality Assurance
Quality Control
Manufacturing/Production
Notes:
Show Owner:
ComplianceOnline
Sponsorship:

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Show Owner
ComplianceOnline

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