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.  


EUR 225 including course material and certificate.

More Info & Registration: