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

ComplianceOnline

Monday, October 14, 2019 at 8:30 AM - Tuesday, October 15, 2019 at 4:30 PM (EDT)

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

Ticket Information

Ticket Type Sales End Price Fee Quantity
Seminar One Registration Ended $1,899.00 $0.00

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

Event Details

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.

 

Who will benefit:

This interactive course is specifically developed for individuals, who are responsible for the design, development, manufacturing, marketing, and distribution of IVD products. This course is highly recommended for personnel involved in any of the following functions:

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

Speaker:

Robert Di Tullio

Robert Di Tullio
President, Di Tullio Consulting Inc

Robert Di Tullio is an experienced leader in the diagnostics industry. For 45 years, he has held various positions with multiple organizations, with a particular emphasis on regulatory, quality and clinical affairs management.

Robert has provided companies, large, small and start-up, with the vision, strategy and leadership to promote commercial success while assuring compliance with global regulations and initiatives in the competitive marketplace.

As a solutions oriented leader, Robert has consistently achieved positive results in all industry aspects for regulatory and operational processes and systems.


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

 

Note: Use coupon code < REFERRAL10 > and get 10% off on registration.

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

When & Where


Sheraton Boston Hotel
39 Dalton Street
Boston, MA 02199

Monday, October 14, 2019 at 8:30 AM - Tuesday, October 15, 2019 at 4:30 PM (EDT)


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Organizer

ComplianceOnline

At ComplianceOnline, we are focused on:

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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