Training Features

Companion Diagnostics, Clinical Trial Assays and Combined Pharma Studies under the IVDR

Gain practical insights into IVDR requirements for companion diagnostics and clinical trial assays to ensure regulatory compliance and successful submissions.
Format

Virtual Training

Level

Advanced

Date

15 September 2026

Time

14:00 - 16:00 CET

Duration

2 hours

Trainer

Lorry Weaver

Certificate

Certificate included

Price

€ 295 or equivalent currency

Training on IVDR Requirements for Companion Diagnostics and Clinical Trial Assays

The EU In Vitro Diagnostic Regulation (IVDR) 2017/746 has introduced stricter requirements for companion diagnostics (CDx), Clinical Trial Assays and IVDs used in pharmaceutical clinical trials. CDx and Clinical Trial Assays play a critical role in precision medicine and pharma clinical trials, ensuring based on biomarker screening the identification of patient populations who will benefit most from innovative therapies. 

Led by Lorry Weaver, this interactive training provides an in-depth overview of the IVDR requirements for CDx and Clinical Trial Assays, including classification, performance evaluation, clinical evidence generation, and interactions with regulatory authorities. Participants will also learn how to navigate combined pharma-clinical trials and clinical performance studies, coordinate submissions with the European Medicines Agency (EMA), and ensure compliance with the evolving regulatory landscape.

Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
The EU In Vitro Diagnostic Regulation (IVDR) 2017/746 has introduced stricter requirements for companion diagnostics (CDx), Clinical Trial Assays, and IVDs used in pharmaceutical clinical trials. These devices are essential for precision medicine, enabling the identification of patient populations most likely to benefit from innovative therapies.

This training provides a comprehensive overview of IVDR requirements, covering CDx classification, performance evaluation, clinical evidence generation, and interactions with regulatory authorities. Participants will also learn best practices for navigating combined pharma-clinical trials, preparing clinical performance study submissions, and coordinating with the European Medicines Agency (EMA) to ensure compliance with the evolving regulatory landscape.
Key Learning Objectives
  • Understand IVDR requirements for companion diagnostics, Clinical Trial Assays, and investigational IVDs.
  • Learn about best practices for development and validation of CDx and Clinical Trial Assays under the IVDR.
  • Understand the process and requirements for combined pharma and clinical performance study authorization.
  • Gain insights into the requirements for performance evaluation and clinical evidence generation for CDx.
  • Understand the regulatory pathways for approval of CDx and the related therapeutic product.
  • Understand post-market surveillance and performance follow-up requirements for CDx.
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training session
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Training Dates
This training is delivered in one session, lasting 2 hours, providing a focused and efficient learning experience. The sessions will take place on 15 September 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If this training date is not suitable, an additional sessions will be held on 12 May 2026. Additional information can be found on the registration page.
Who Should Attend?
  • Regulatory Affairs professionals working with Clinical Trial Assays and CDx.
  • IVD and pharmaceutical manufacturers developing Clinical Trial Assays and CDx.
  • Clinical trial sponsors and CROs involved in IVD-related studies.
  • Professionals responsible for coordinating clinical study submissions.
  • Quality Assurance professionals ensuring IVDR compliance.
  • R&D teams developing and validating biomarker screening assays, clinical trial assays and CDx.
  • Market access and business development professionals in diagnostics and pharma.
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Regulatory Framework for Companion Diagnostics and Clinical Trial Assays: Covers IVDR definition and classification of CDx, applicability for clinical trial assays and IVDs in pharma trials, differences between CDx, other IVDs, and RUO assays, requirements for in-house assays, and regulatory interactions with Notified Bodies and Competent Authorities 
  • Companion Diagnostics (CDx) under the IVDR: Explains CDx definition, intended use, common development pathways, coordination between IVD manufacturers and pharma companies, risk management under ISO 14971 and IVDR Annex I, and clinical evidence/performance evaluation requirements 
  • Clinical Trial Assays and Investigational IVDs: Covers IVDR requirements for biomarker screening and clinical trial assays, development and validation including analytical and clinical performance studies, and EMA and Competent Authority expectations 
  • Combined Pharma and Clinical Performance Studies: Addresses study authorization, ethical review, generation of clinical performance study submission packages, responsibilities of pharma and diagnostic sponsors, and strategies for study submission 
  • Conformity Assessment and Post-Market Requirements: Focuses on CDx conformity assessment, EMA review coordination by the Notified Body, and post-market surveillance (PMS) and performance follow-up (PMPF) obligations.

Flexible Online Training Designed for MedTech Professionals

Participate from anywhere with our interactive virtual format, designed to fit your schedule while delivering in-depth, actionable content tailored to real-world regulatory challenges.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

Learn directly from regulatory experts with practical industry experience and gain clear, actionable insights into navigating x.

Expert-Led Training for Practical Compliance

Meet the Trainer

Lorry Weaver

Lorry Weaver is a Principal Consultant at Qserve with over 30 years of experience in US FDA and European medical device regulations, specializing in 510(k) submissions, CE marking, and regulatory strategies for a broad range of devices including in vitro diagnostics and companion diagnostics.