2-Day Virtual Seminar by Ex-FDA Official

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

BY: Haja Sittana El Mubarak, Senior IVD consultant, Biologics consulting Inc

Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

March 11-12, 2021
(11:00 AM to 06:00 PM EST)
Virtual Seminar
  • Course Description
  • Agenda
  • Speaker
  • Price/Register

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
Day 01(11:00 AM - 6:00 PM EST)
  • UNITED STATES
  • Session 1
    • 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
  • Session 2:
    • Overview of US-FDA Regulations for IVDs
  • Lunch Break:
  • Session 3:
    • Determination of classification & Identification of Predicate Device(s)
    • Development of Regulatory Strategies and Pathways for IVDs
    • Special consideration of IVD labeling requirements
  • Afternoon Break:
  • Session 4:
    • 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 02(11:00 AM - 6:00 PM EST)
  • EUROPE
  • Session 5:
    • Overview of European IVD Regulations
    • Understanding of EU MDD 98/79/EC for IVD and applicable MEDDEV documents
  • Morning Break:
  • Session 6:
    • 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:
  • CANADA
  • Session 7:
    • Overview of Canadian Medical Device Regulations (CMDR) for IVDs
    • Understanding similarities and differences between U.S. and Europe regulations
  • Afternoon Break:
  • Session 8:
    • 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
Haja Sittana El Mubarak
Haja Sittana El Mubarak Senior IVD consultant, Biologics consulting Inc

Dr. El Mubarak is a Senior IVD consultant at Biologics consulting Inc. She has over 12 years of FDA experience spent primarily in the Center of Devices and Radiological Health (CDRH). Haja served for five years as the agency subject matter expert in Serological and Molecular Diagnostics of Viral Infections, representing the agency in providing consults, outreach and training to national and international stakeholders. Dr. El Mubarak has extensive experience in pre and post market regulation of in vitro diagnostic devices (IVDs) and is an expert in working with a variety of submission types including; 510(k)s, PMAs, IDEs, de novos, pre- submissions, 513 (g)s, and post-market submission.

Dr. El Mubarak has extensive knowledge of FDA regulations and policies, solving complex regulatory policy issues and communicating regulatory policies to internal and external stakeholders. She has an established record in developing regulatory guidance, Agency reports, internal policies, GHTF documents and CLSI documents.

Dr. El Mubarak has over 20 years of technical experience, in diagnostic virology, molecular biology, serology and IVD device development in clinical laboratory, academic research and regulation. She is an talented communicator, experienced in problem solving, stakeholder engagement and negotiation. She has taken multiple leadership roles in the agency in the areas of strategic planning, change management, training, outreach and championing diversity in workplace.

Register Now

Online using Credit card

$1,699.00

(One Dial-in One Attendee)

March 11-12, 2021, Virtual Seminar
(Registrations till January 30, 2021 - $1699)
(Registrations after January 30, 2021 - $1999)


For discounts on multiple registrations, contact customer care at +1-888-771-6965.

Other Registration Options

By order form / PO#

Payment Modes

By Check -

To pay by check please contact customercare@grcseminars.com

By Wire -

Register / Pay by Wire TransferPlease contact us at +1-888-771-6965 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event »

Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ customercare@grcseminars.com

Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future GRC Seminars event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

You Recently Viewed