Summary
As regulatory expectations evolve, model-informed drug development (MIDD) is no longer optional, it is increasingly central to decision-making, particularly in the context of streamlined development programs and single pivotal studies. Yet, while the use of PBPK, QSP, and other mechanistic models is growing, regulatory acceptance still hinges on one critical factor: credibility.
What makes a model “credible” in the eyes of regulators? Why do some models meaningfully inform decisions, while others raise concerns or are discounted entirely?
In this follow-up to Regulatory Horizons: Global Insights 2026, former regulators and clinical pharmacology experts will provide practical guidance on how to increase regulatory confidence in your models. The discussion will go beyond theory to focus on real-world decision-making: identifying common red flags, defining appropriate context of use, and demonstrating the totality of evidence needed to support model-informed claims.
The session will also explore how the evolving regulatory landscape, including increased reliance on single pivotal studies, is raising the bar for mechanistic and quantitative evidence, making well-positioned and well-communicated models more important than ever.
Attendees will leave with actionable strategies to move from simply including models in submissions to ensuring they are trusted, decision-enabling components of the regulatory package.
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Eva Berglund, PhD
Senior Director, Clinical Pharmacology and Regulatory StrategyDr. Eva Gil Berglund is a pharmacist by training and has a PhD in Clinical Pharmacology, both from Uppsala University, Sweden. She has been a Clinical Pharmacology reviewer at the Swedish Medical Products Agency for over 20 years and a Senior Expert for 12 years, working with all types of molecules in marketing applications, clinical trials and scientific advice procedures in the EMA Network of National agencies. Eva has been working in all therapeutic areas and has extensive knowledge in antivirals, antibiotics, CNS active drugs, oncology, rheumatology, inhalation products etc.
Blaire Osborn, PhD
Senior Director, Clinical Pharmacology and Translational MedicineDr. Osborn has over 25 years of drug development experience in the areas of clinical pharmacology and pharmacokinetics. She has focused primarily oncology and anti-infectives. Before joining Certara, she was a reviewer in the Office of Clinical Pharmacology, US Food and Drug Administration, in the Division of Cancer Pharmacology, CDER where, she participated in the assessment of multiple dose justification submissions under Project Optimus. Prior to working in the FDA, she was a clinical pharmacologist in the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institute of Health (NIH).
Justin Hay, PhD
Senior Director, Clinical Pharmacology ConsultingDr. Hay joined Certara in 2022 with 25+ years of clinical pharmacology experience having started his career as Senior Clinical Scientist at the Centre for Human Drug Research (CHDR), Leiden. More recently he worked as Senior Pharmacokinetics Assessor and Deputy Unit Manager at the Medicine and Healthcare Products Regulatory Agency (MHRA), UK where he also had a leading role with the Access Consortium (Regulatory agencies of Australia, Canada, Singapore, Switzerland and UK).
Justin has also been a member of the EMA’s former Modelling and Simulation Working Party (MSWP). He has a special interest in biologics, CNS research, pain management and pediatric pharmacology. Justin has a PhD from the University of Adelaide, Australia.
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