Plenary Session

WEDNESDAY, 23 MAY

11:35 Plenary Introduction

John Carrano, CEO, Paratus Diagnostics, LLC, United States

11:45-12:15 The New EU IVD Regulation - What Will It Mean for Your Lab?

David_BartonDavid E. Barton, PhD, Chief Molecular Geneticist, National Centre for Medical Genetics, Our Lady's Hospital for Sick Children, Ireland

In May 2017, Europe passed a new Regulation on in vitro Diagnostic Devices (IVDs). The regulation sets up a framework for controlling the market for diagnostic tests within the EU, setting out standards for the design and manufacture of in-vitro diagnostic devices (IVDs) and providing mechanisms for the oversight of these standards. This presentation will outline the content of the new regulations, with a particular focus on molecular diagnostics, and highlight the new requirements for clinical laboratories.

12:15-12:25 Introduction: Medicinal Product Regulators Point of View: Scientific-Regulatory Aspects of Companion Diagnostics and Challenges for Validation during Clinical Co-Development (Quality-Related Aspects)

Jorg_EngelbergsJorg Engelbergs, PhD, Scientific Expert and Assessor Biomedicines (Quality, Non-Clinic & Personalized Medicine), Section Mono- and Polyclonal Antibodies, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany

In Europe, the legislation for marketing of medicinal products (MP) and IVDs including predictive biomarker-based assays (Companion Diagnostics, CDx) are not directly linked which is challenging for co-development. The new IVDD involves MP regulators in the CDx review process for CE marking. This presentation will outline from the perspective of MP regulators the scientific-regulatory challenges for technical validation of CDx. Differences between exploratory assays and assays used for patient stratification, as well as aspects for complex assays will be addressed.

12:25-13:30 PANEL DISCUSSION: Changing Landscape for IVDs in the EU

Moderator:
Charlotte_RyckmanCharlotte Ryckman, Covington & Burling LLP, Belgium


Panelists:
David_BartonDavid E. Barton, PhD, Chief Molecular Geneticist, National Centre for Medical Genetics, Our Lady's Hospital for Sick Children, Ireland


Jorg_EngelbergsJorg Engelbergs, PhD, Section Mono- and Polyclonal Antibodies, Scientific Expert Biomedicines, Quality, Non-Clinic & Personalized Medicine (Biomarker/CDx), Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany


Maria_NevesMaria Judite Neves, Health Products Director, Health Products Directorate, INFARMED - National Authority of Medicines and Health Products, Portugal


Sue_SpencerSue Spencer, Global Service Director, Regulatory, UL, United Kingdom


Andreas_StangeAndreas F. Stange, PhD, Vice President, MHS Global IVD, TUV SUD, Germany


Doris-Ann_WilliamsDoris-Ann Williams, MBE, Chief Executive, British In Vitro Diagnostics Association (BIVDA), United Kingdom

  • Practical impact of the new IVD Regulation
  • Regulatory aspects of companion diagnostics
  • Challenges for validation
  • Role of IVDs in the market

* 活动内容有可能不事先告知作更动及调整。