In Vitro Diagnostics for Pharma and Biotech – In-house devices (LTD) / CDx in Europe

by | Nov 28, 2023 | Upcoming Trainings

Speaker: Dr Silvia Anghel, Head of IVD Group

Date: May 2nd 2024, Online

Duration: 2 hours | 9:00 AM – 11:00 AM (EST), 3:00 PM – 5:00 PM (CET)

Training Objectives:

The training will clarify some of the interfaces that have been created between medicinal product-oriented clinical trials and the requirements for assays used in the context of clinical trials by the recent application of the European In Vitro Diagnostic Regulation (EU 2017/746). 

The objectives of the training are:  

    • Understand EU IVD Regulation (EU 2017/746 EC, IVDR) 
    • Understand how the clinical trials will be impacted by the requirements of IVD Regulation. 
    • Understand the options for ensuring the availability of a test device on the EU market.

Training Content:

  • EU Regulatory Framework for In Vitro Diagnostic (IVD) devices  
  • Qualification and Classification as In Vitro Diagnostic device 
  • Go to Market process for CE-marked device versus In- house developed test (LDT) 
  • Pros & Cons: CE-marked devices versus LDTs 
  • Requirements of assays used during clinical trials 

Training Format:

  • Presentation with interactive discussions 
  • Exercises during the training 
  • End of training assessment (participants will receive a training certificate)

Who Should Attend:

Regulatory and Clinical Affairs managers from Pharmaceutical companies that oversee the setting of clinical trials, management of assays during clinical trials and/or ensure the post-market accessibility of patients to companion diagnostic tests, as well as Medical Laboratory managers that act as Central Laboratory during clinical trials.  

Price:

EUR 225 including course material and certificate.

More Info & Registration:

http://education-veranex.talentlms.com