The global shift toward precision medicine has transformed drug development, introducing targeted therapies and companion diagnostics that could provide more effective treatments. However, this evolution has also brought significant regulatory complexity — particularly in Europe, where the In Vitro Diagnostic Regulation and Clinical Trials Regulation have reshaped expectations for sponsors.
This interactive half-day workshop is designed for regulatory professionals seeking clarity on the scientific and regulatory framework for biomarker-driven drug development. Participants will gain a fundamental understanding of biomarkers, their role from proof-of-concept through pivotal trials, and the regulatory requirements for investigational diagnostics used alongside investigational drugs.
Through case studies, group exercises, and real-world examples, attendees will explore:
What defines a biomarker and its integration into clinical development regulatory expectations under IVDR and CTR for investigational diagnostics, challenges and limitations of bridging studies, practical application of IVDR rules to trial protocols and schedules of assessments and some of the key considerations for marketing authorizations of both drugs and in vitro diagnostics.
By the end of the workshop, participants will leave with actionable insights to navigate the perceived complexity of current regulations and apply best practices in biomarker-driven clinical trials.
Learning Objectives
- Upon completion, participants will be able to define and classify biomarkers and explain their role in clinical development from early-phase studies to pivotal trials.
- Upon completion, participants will be able to demonstrate an understanding of the regulatory requirements for investigational diagnostics under IVDR and Clinical Trials Regulation.
- Upon completion, participants will be able to apply IVDR principles to real-world clinical trial documents such as protocols and schedules of assessments.
Who Should Attend?
Regulatory affairs professionals, clinical development teams, diagnostic/IVD specialists, and anyone involved in biomarker strategy or managing IVDR/CTR requirements for clinical trials. This workshop is ideal for those seeking practical guidance on integrating biomarkers and investigational diagnostics into drug development.
Audience 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.
Agenda
Welcome, Introductions & Session Framing
Module 1 – Foundations of Biomarkers in Clinical Development
Speaker: Amber McNair, 25 minutes
Module 2 – Regulatory Expectations for Investigational Diagnostics (IVDR + CTR)
Speaker: Amber McNair, 30 minutes
Module 3 – The EU Biotech Act: What It Means for Biomarker-Driven Trials‑Driven Trials
Speaker: Vladimir Vujovic, 30 minutes
Module 4 – Operationalising Biomarker Requirements in Trials
Speakers: Amber McNair, 25 minutes
Module 5 - Future-Ready Clinical Trials: The Path Ahead
Speaker: Vladimir Vujovic, 20 minutes
Final Wrap Up & Take Home Tools
Speakers: Amber McNair & Vladimir Vujovic
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speaker
Amber McNair BSc(Hons), RSci, BCMAS, mTOPRA
