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Building Global Submissions from the Ground Up - SARS-CoV-2 Case Study

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Building Global Submissions from the Ground Up - SARS-CoV-2 Case Study

This is an On-demand recording from October 2020.

2020 has been a year of challenges, but it has also provided experiences from which we can reflect and learn. In the diagnostic world, manufacturers have had to develop new devices at breakneck speak and get them to market to help battle a public health pandemic. As our knowledge of COVID-19 matures and as we understand more about how tests can help at difference points in the care pathway, manufacturers are now looking to repurpose emergency use applications into global registrations.


Although COVID-19 has put the design and development process into a pressure cooker, it is still necessary to have a well thought-out plan for moving your IVD along a development pathway to succeed for emergency use applications as well as for traditional global submissions. Whether you are developing SARS-CoV-2 assays or are just interested how to efficiently build your global submissions, this webcast aims to share some of those best practices using SARS-CoV-2 as a case study.


Learning Level:

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.


Learning Objectives:

Upon the conclusion of the program you will:

·         Understand how to efficiently compile IVD submission for global submissions

·         Understand how to develop submissions in tandem with the design of the product

·         Have learned tips and common pit falls to avoid when generating global IVD submissions


Who Should Attend:

·         IVD Regulatory professionals

·         IVD Design teams

·         Developers of SARS-CoV-2 assays



·         Christie Hughes, IVD consultant, Qserve Group

Christie Hughes has over 20 years’ experience with thorough knowledge of the IVD sector in quality, regulatory, auditing and training. She has versatile knowledge of quality assurance and regulatory affairs with hands on experience and expertise in quality management systems, regulatory affairs, project management and clinical affairs. Between 1996 and 2016, she held roles including QA Manager, Quality & Compliance Manager, QA Director, Product Manager for microRNA tests, and Senior Manager Regulatory Affairs at IVD multinationals Luminex and Thermo Fisher Scientific. Since 2017, Christie has run her own consulting firm, Integrys Consulting, where she has worked on several projects in the QA/RA IVD area for both Qserve and her own firm.


Christie has a master’s in public health degree in epidemiology and a bachelor’s degree in biology/medical technology, is a certified medical technologist (medical laboratory scientist) through the American Society for Clinical Pathology (ASCP) and is a certified quality auditor through the American Society for Quality (ASQ).

·         Lorry Weaver, US principal consultant, regulatory affairs, Qserve Group

Lorry Weaver has over 30 years of experience in the medical industry, working in large multi-national corporations, mid-sized companies, clinical laboratories, and the consulting business. In addition to her domestic roles, she has held global responsibilities in Europe, Canada, Japan and China.  In this time, Lorry has developed regulatory and quality expertise spanning a broad range of product areas, including Class II cardiovascular and renal devices, Class III cardiovascular implants, in vitro diagnostics ranging from standard microbe identification and antimicrobial susceptibility panels to genetic sequencing of bacteria, viruses, and tumor tissue as companion diagnostic (CDx) assays using next-generation sequencing (NGS). She has thorough knowledge of developing US regulatory strategies, engaging with FDA through pre-submissions (Q-subs) to partner with FDA and the manufacturer in developing novel regulatory pathways, writing IDEs, 510(k)s, and PMAs. 


Lorry has a bachelor’s in microbiology with a minor in chemistry from Northern Arizona University and an MBA with emphasis in marketing from CSU-Sacramento. She is also a licensed Medical Technologist and Clinical Laboratory Scientist by the American Society for Clinical Pathology (ASCP), the National Credentialing Agency for Laboratory Personnel, Inc. (NCA), and the State of California.

·         Sue Spencer, head of IVD, Qserve Group

Sue Spencer has over 30 years’ experience in the Medical Device and IVD industries where she has held positions in R&D, Manufacturing and Quality Assurance. She has worked in the notified body arena since the initial introduction of the Medical Devices and IVD Directives and is now involved with the development of the new regulations. She has over 14 years’ experience working for several notified bodies; where she chaired the IVD subgroup of NBMED coordinating the notified body responses to the IVDR and participated in the Commission IVD Technical Work Group.

Sue is presently a consultant with Qserve Group where she leads an experienced team to support manufacturers develop strategies, prepare technical documentation, and implement the requirements of the IVDR, FDA and other regions.

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