Live Q&A Session with Danielle Giroud and Jiří Šilar

Date: 10 September 2026 | Time: 14:00 CET
Format: Online Session (Zoom)

Estimands have become an increasingly important topic in clinical research, yet they are often perceived as being complex or reserved for statisticians. In reality, many clinical research professionals already apply the principles of estimands when designing clinical investigations—they simply may not refer to them by this terminology.

During this live Q&A session, Danielle Giroud and Jiří Šilar will begin with a concise 15–20 minute introduction to estimands from both the clinical and statistical perspectives. Using practical examples, they will explain what estimands are, why they matter, and how they support the design of robust medical device clinical investigations.

The remainder of the session will be dedicated to your questions. Participants are encouraged to ask questions live during the event or to submit them in advance when registering, allowing the speakers to address the topics that matter most to the audience.

Whether you are discovering estimands for the first time or looking to deepen your understanding of this evolving concept, this session will provide practical insights and an open forum to discuss real-world challenges with two experienced experts in the field.

Danielle Giroud
Founder, Chief Executive Officer MD-CLINICALS & WMDO

With close to 40 years of experience, Ms. Danielle Giroud is an internationally recognized clinical research and regulatory expert within the global medical device industry. She has shared her extensive knowledge and experience with multi-national companies, organizations, and start-ups from around the world to help bring their products to market quickly and efficiently. Ms. Giroud is also known for her contribution and engagement as founder and senior faculty board member of the World Medical Device Organization (WMDO). Since 2008 she is the convener for the expert group on clinical investigations (TC 194 WG4) for the ISO 14155 and clinical evaluation for the ISO 18969, and functions as a liaison with the EU Commission – Clinical Investigation and Evaluation, Performance Studies and Evaluation (CIEPSE) task force and other regulatory authorities throughout the world.

Jiří Šilar
Biostatistician at the Institute of Biostatistics and Analyses

Jiří holds a master’s degree in Mathematical Biology and has worked as a Biostatistician at the Institute of Biostatistics and Analyses for the past 11 years. He specializes in the design, statistical analysis, and interpretation of clinical trials and research studies across a wide range of therapeutic areas. Alongside his work on clinical projects, he provides statistical consulting, supporting clients in addressing complex methodological challenges and developing solutions tailored to their research needs. His expertise spans study design, sample size determination, SAS programming, CDISC-compliant data labelling, data interpretation, and the effective communication of statistical findings to clients and project teams.

Submit Your Questions

Participants are encouraged to submit their questions in advance to:

support@iceps-mdivd.org

Questions received before the session will help shape the discussion and ensure that key implementation challenges and practical concerns are addressed during the live event.

Practical Information

• Date: 10 September 2026
• Time: 14:00–15:30 CET
• Duration: 1 hour 30 minutes
• Format: Online via Zoom
• Registration Fee: €15 for ICEPS members and 35€ for non-members (VAT excl.)
• Zoom Access: The Zoom link and connection details will be sent by email.
• Recording: The session will be recorded, and access to it will be only for ICEPS members.

Important Information

Please note that this event is a live Question & Answer session only.

The purpose of the session is to provide clarification and discussion on the implementation of Estimands. Participants will have the opportunity to ask questions and exchange directly with the expert speaker.

This session is not a training course, and participation does not provide a certificate of attendance, training completion, or certification.

Your Zoom access link is personal and may not be shared. Any participant not registered through ICEPS may be removed from the webinar without notice.