Event

RAPS Webcast | Building Global Submissions from the Ground Up | SARS Co-V-2 Case Study

October 07, 2020 - October 07, 2020 / Global

Date: October 7th, 2020

Time: 18:00-19:00 CEST | 9-10am PST | 12-1pm EDT

Location: Virtual, Live Q & A

Language: English

Introduction: 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
Sue Spencer
Lorry Weaver
Post date: September 10, 2020
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