Attendees will receive a basic overview of performance study reviews of IVD devices and companion diagnostics according to EU IVDR 2017/746. The speaker will cover best practices for planning, design, and conduct, tailored as needed to pharma and biotech firms going to market into diagnostics within or partnering with diagnostic firms. The workshop topics range from establishing a robust diagnostic device QMS and strategies for performance claim validations, bridging from analytics to clinical performance and harmonizing with requirements for gaining access to dual‑market (drugs and diagnostic) pathways.
Insights will include selection and qualification of vendors/suppliers, selection to outsource performance study diagnostic endpoints, device requirement considerations from IVDR to new FDA QMSR. Attendees will be able to take home an outline for working with a diagnostics firm and co-developing performance study plans and lists of requirements framework to satisfy both Notified Bodies and Competent National Authorities (CNAs).
Learning Objectives
- Delineate the essential elements of IVDR 2017/746 Annex XIV for performance testing of an analytical and clinical PE, contrastic regulatory status for pharmaceutical GMP-based QMS for applications of IVDs.
- Work with vendors on quality agreements and overall performance study plans, purpose for usage, rationale method, both as per EU IVDR Annex XIII and Notified Body specifications for CE marking investigational vs commercial diagnostics bound for both markets.
- Apply IVD performance study results up through higher levels of your QMS paperwork (i.e., technical documentation, risk management files, design history files), preparing you for regulatory submissions and NB audits.
Who Should Attend?
Clinical Affairs, Clinical Operations, Regulatory Affairs, Quality Assurance, Person Responsible for Regulatory Compliance (PRRC), Patient Safety, Risk Management professionals, Project Management, Research & Development Quality.
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Agenda
|
Time ET |
Topic |
|
9:00 – 9:05 am (5 min) |
Opening Remarks & Strategic Framing Objective: Set regulatory tone and urgency.
Parallel lens: IVDR vs FDA IDE |
|
9:05 – 9:25 am (20 min)
|
Section I – Regulatory Foundations: IVDR Architecture for Performance Studies
Key Focus: |
|
9:25 – 9:45 am (20 min) |
Section II – IVDs vs Companion Diagnostics in Phase 2/3 Trials 1. Companion Diagnostic Definition Under IVDR 2. Biotech + Diagnostic Company Risk Zones 3. Vendor Engagement with CROs/CDMOs and Co-Development Strategy
|
|
9:45 – 9:55 am (10 min) |
BREAK |
|
9:55 – 10:20 am (25 min) |
Section III – Deep Dive: Annex XIV Performance Study Requirements: How to Prepare a Basic Performance Study Plan
|
|
10:20 – 10:35 am (15 min)
|
Section IV – Vendor Diagnostic Oversight
Cross-comparison with IVDR decentralized performance study requirements. |
|
10:35 – 10:50 am (15 min) |
Section V – Quality System Integration for Biotech Sponsors This is where most biotech companies fail Why IVDR requires a Quality Management System Importance of documentation and traceability Role of the PRRC (basic explanation only 1. IVDR QMS Expectations
Basic link between:
Vigilance & trend reporting |
|
10:50 – 10:55 am (5 min)
|
Section VI – Common NB Deficiencies & Inspection Trends Top 3 Major Findings:
|
|
10:55 – 11:00 (5 min)
|
Q&A Session Encourage targeted regulatory strategy questions. |
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speakers
Leonel Vanegas
