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.
Registration Fees & Deadlines
Present – 29 March 2026 Member $315 | Nonmember $370
30 March – 29 April 2026: Member $370 | Nonmember $430
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
Half‑Day Agenda (4 hours)
Welcome, Introductions & Session Framing
- Moderator introduction
- Overview of the session goals
- Context setting: evolution of biomarker-driven development and EU regulatory complexity-driven development and EU regulatory complexity-driven development and EU regulatory complexity-driven development and EU regulatory complexity‑driven development and EU regulatory complexity
Module 1 – Foundations of Biomarkers in Clinical Development
Speaker: Amber McNair, 25 minutes
- What defines a biomarker?
- Categories: prognostic, predictive, PK/PD, safety, enrichment, target engagement
- How biomarkers shape drug development strategies (proof of concept → pivotal trials
- Transitioning biomarkers from exploratory to regulated use
- Example use cases in oncology, rare disease, immunology
Activity: “Which biomarker is this?” classification exercise [POLL 5 minutes]
Module 2 – Regulatory Expectations for Investigational Diagnostics (IVDR + CTR)
Speaker: Amber McNair, 30 minutes
- CTR requirements for diagnostics used in medicinal product trials
- IVDR obligations for investigational IVDs
- How regulators assess risk, performance, and classification
- Documentation expectations: Annex II/III technical files, performance plans, risk management
- Practical interpretation of IVDR Articles 5, 10, 58–70 in the clinical setting
- Differences between RUO, CE‑IVD, and Investigational IVD
Case Study: Applying IVDR classifications to a biomarker used in screening and enrolment [BREAK OUT ROOMS 10 minutes]
Q&A break (5 minutes)
Comfort Break
Module 3 – The EU Biotech Act: What It Means for Biomarker-Driven Trials‑Driven Trials
Speaker: Vladimir Vujovic, 30 minutes
- Overview of the Biotech Act’s objectives
- Expected implications for:
- Evidence requirements
- Integration between CTR, MDR/IVDR
- Cross‑border oversight
- Requests for Information (RFIs): what might change?
- Potential future models for integrated review within CTIS
- Early authority viewpoints & anticipated guidance gaps
Module 4 – Operationalising Biomarker Requirements in Trials
Speakers: Amber McNair, 25 minutes
- Translating biomarker strategy into protocol design
- Schedules of assessments: aligning IMP and IVD requirements
- Evidence needs for exploratory vs regulated biomarker endpoints
- Bridging studies: challenges and limitations
- Site activation considerations under CTR/IVDR
- Quality management and lab readiness
[Group exercise 5 minutes]: Reviewing a protocol excerpt and identifying gaps related to biomarker and IVD compliance
Comfort Break
Module 5 - Future-Ready Clinical Trials: The Path Ahead
Speaker: Vladimir Vujovic, 20 minutes
- CASE STUDY [BREAK OUT ROOMS 10 minutes]
- How will RFI pathways evolve under the Biotech Act?
- What does “integrated assessment” look like in reality?
- How can sponsors prepare now?
- Pain points and system inefficiencies
- Where alignment is improving—and where uncertainty remains
Audience Q&A (embedded)
Final Wrap Up & Take Home Tools ‑Up & Take‑Home Tools
Speakers: Amber McNair & Vladimir Vujovic
- Summary of key messages
- Top 10 practical tips for biomarker-driven trials under CTR/IVDR-driven trials under CTR/IVDR-driven trials under CTR/IVDR-driven trials under CTR/IVDR-driven trials under CTR/IVDR‑driven trials under CTR/IVDR
- Checklist for investigational diagnostic readiness
- Where industry can expect further updates (EC COMBINE, MDCG, Biotech Act guidance)
- Closing remarks and next steps
Speakers
Amber McNair brings a distinctive blend of deep laboratory expertise with advanced regulatory knowledge to drive innovation in biomarker development and companion diagnostics. As a previous anatomic pathology laboratory manager in a global central lab, Amber gained hands-on experience in histopathology workflows, diagnostic assay validation, and quality systems under ISO and CLIA standards. This technical foundation enables her to bridge the gap between scientific rigor and regulatory compliance in complex clinical trial environments. With over six years in regulatory affairs, Amber specializes in oncology and internal medicine, focusing on biomarker-driven drug development and investigational device studies.
Vladimir Vujovic, holds a master’s of pharmacy degree and has been working in the realm of regulatory affairs for more than a decade, primarily in the clinical research sector. His expertise spans medicinal products, clinical trials, clinical investigations of medical devices, and evaluations of IVDs. He took the lead in IVDR preparedness efforts within his organisation, as well as in industry associations such as ACRO, EUCROF, the medical device committee of the local institute for standardisation (ISO) and others.
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 support@raps.org. 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 support@raps.org 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
support@raps.org.