Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada: 2-day In-Person Seminar

By: Robert Di Tullio, President, Di Tullio Consulting Inc
Location :- Sheraton Boston Hotel, MA | Monday, October 14, 2019 | Tuesday, October 15, 2019

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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

Course Outline

Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

Welcome and Introduction

UNITED STATES

Session 1: 09:00 AM – 10:30 AM

  • Evolving technologies and challenges of In-vitro Diagnostics (IVD) products
  • Why the regulators need separate regulations even IVD is considered a device?
  • Know the process and players at OIR (aka OIVD) of CDRH and Health Canada

Morning Break: 10:30 AM – 10:45 AM

Session 2: 10:45 AM – 12:15 PM

Overview of US-FDA Regulations for IVDs

Lunch Break: 12:15 PM – 1:15 PM

Session 3: 1:15 PM – 2:45 PM

  • Determination of classification & Identification of Predicate Device(s)
  • Development of Regulatory Strategies and Pathways for IVDs
  • Special consideration of IVD labeling requirements

Afternoon Break: 02:45 PM – 03:00 PM

Session 4: 03:00 PM – 04:30 PM

  • Determine the type of the required pre-market submission for your IVD
  • Format and Content of 510(k), Pre-IDE, IDE and PMA
  • What is a Clinical Laboratory Improvement Amendment (CLIA) of 1988?
  • Preparation and submission for CLIA Waiver Application
Day Two (8:30 AM – 4:30 PM)

EUROPE

Session 5: 09:00 AM – 10:30 AM

  • Overview of European IVD Regulations
  • Understanding of EU MDD 98/79/EC for IVD and applicable MEDDEV documents

Morning Break: 10:30 AM – 10:45 AM

Session 6: 10:45 AM – 12:15 PM

  • Special consideration to Classification Rules for IVDs
  • Conformity Assessment for CE Marking
  • Special Labeling and electronic Labeling Requirements for IVDs
  • Preparation of Technical File or Design Dossier

Lunch Break: 12:15 PM – 1:15 PM

CANADA

Session 7: 1:15 PM – 2:45 PM

  • Overview of Canadian Medical Device Regulations (CMDR) for IVDs
  • Understanding similarities and differences between U.S. and Europe regulations

Afternoon Break: 02:45 PM – 03:00 PM

Session 8: 03:00 PM – 04:30 PM

  • Format and Content of Canadian Medical Device License (MDL) Application
  • Inclusion of the required data and information for MDL application
  • Conclusion & Summary of the course

Meet Your Instructor

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.

Venue

Location :

Sheraton Boston Hotel
39 Dalton Street,
Boston, MA 02199 USA
Tel: +1-617-236-2000


October 14-15, 2019



How to Reach

General Driving Directions:

Driving Directions from Boston Logan International Airport (BOS)
  • Get on MA-1A S from Airport Rd - Departure Level3 min (1.0 mi)Continue on MA-1A S.
  • Take MA-28 S and Storrow Dr to Charlesgate.
  • Take the exit toward Fenway from Storrow Dr8 min (4.3 mi)
  • Take Boylston St to Dalton St5 min (0.7 mi)
Driving Directions from Manchester-Boston Regional Airport (MHT)
  • Get on I-93 S in Londonderry from NH-28 S9 min (4.8 mi)Follow I-93 S to Charlesgate in Boston.
  • Take the exit toward Fenway from Storrow Dr44 min (45.1 mi)
  • Take Boylston St to Dalton St5 min (0.7 mi)

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. GRC Seminars is not responsible for any inaccuracies in the same.
Register Online

Register Online

$1,699

Seminar One Registration

October 14-15, 2019, Boston, MA
(For Registrations till September 17, 2019 - $1699)
(For Registrations after September 17, 2019 - $1899)

Early bird seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.
For discounts on multiple registrations, contact customer care at +1-1-888-771-6965.

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Local Attractions of Boston, MA

Boston Public Garden
This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.

Boston Public Library
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Fenway Park
Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.


Museum of Fine Arts
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Museum of Science
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North End
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Old North Church
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