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Paediatric Extrapolation According to ICH E11A
Who it is for
- This is an Expert Discussion Group with a requirement for participation.
- Experience in pediatric clinical research is required.
- Experience with extrapolation is helpful but not required.
What it covers
Pediatric extrapolation is the practice of using data generated in one population - typically adults or an older pediatric age group - to support conclusions about efficacy, safety, or dosing in a younger or different pediatric population.
One of the key aims of extrapolation is to reduce the need to generate new, dedicated pediatric data without compromising efficacy and safety.
The ICH E11A (2024) Guideline on Pediatric Extrapolation (https://www.ema.europa.eu/en/ich-guideline-e11a-pediatric-extrapolation-scientific-guideline) was implemented by the FDA and the EMA in December 2024 and January 2025, respectively.
It is the first standalone ICH efficacy guideline dedicated specifically to pediatric extrapolation methodology, and it sets out a systematic approach for planning, justifying, and executing extrapolation across a pediatric drug development program.
Two core components require documentation:
- Pediatric Extrapolation Concept
- Pediatric Extrapolation Plan
As the pharmaceutical industry orients itself to this new guideline, this EDG aims to bring together regulatory medical writers working in this area to discuss challenges, exchange ideas, and share practical approaches.
Requirements for participants
- Experience in pediatric clinical research is required.
- Experience with extrapolation is helpful but not required.
Divya Bharti (BDS) is a regulatory MW with >13 years of experience in the pharmaceutical industry. Her expertise includes the development of clinical and regulatory documents, project management, and global regulatory submissions. Throughout her career, she has worked in both CRO and pharmaceutical company settings, supporting multidisciplinary development programs across a range of therapeutic areas, with particular experience in pediatric and rare disease development. She currently serves as a submission lead within the Immunology portfolio at Johnson & Johnson Innovative Medicine, where she leads regulatory writing activities for global development and submission projects.
Raquel Billiones has a PhD in Biology and more than 25 years combined experience in scientific and clinical research. She has been a medical writer for >15 years, with core competencies in writing clinical trial and regulatory documents for
pharmaceuticals and medical devices. Her experience also includes transparency, disclosure and patient data protection in clinical trial data reporting. Over the years, she took on a wide range of industry positions, as freelancer, employed regulatory writer, and as head of medical writing departments in the CRO and big pharma settings. Raquel is an active member of EMWA, serving in various roles, including
• Medical Writing editorial board member since 2010, currently Editor-in-Chief
• Education Committee member and workshop leader
• Co-founder of the SIGs on Medical Devices and on Sustainability.
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If you wish to cancel your attendance at the conference, a refund, minus an administration fee of €162, will be made provided your cancellation is made in writing to EMWA head office before 20 October 2026. No refunds will be made after this date.
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