概要

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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By the end of this webinar, attendees will be able to:

Define model credibility from a regulatory perspective
Understand how agencies assess plausibility, assumptions, validation, and fitness for purpose.
Identify common modeling red flags that undermine regulatory confidence
Recognize pitfalls that can lead to questions, delays, or rejection of model-informed evidence.
Apply key principles of ICH M15 and context of use
Ensure models are appropriately designed, justified, and aligned with their intended regulatory purpose.
Demonstrate the totality of evidence needed to support model-informed decisions
Integrate clinical, nonclinical, and mechanistic data to strengthen submissions.
Translate models into regulatory decision-making tools
Effectively link pharmacology, exposure, and clinical outcomes in a way that resonates with reviewers.
Implement strategies to increase regulatory acceptance and trust
Use communication, transparency, and early engagement to improve the likelihood that models are relied upon, not just included.

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This webinar is designed for professionals involved in clinical pharmacology, pharmacometrics, and model-informed drug development (MIDD) who are responsible for generating or defending model-based evidence in regulatory submissions.

Primary audience:

臨床薬理学者
Pharmacometrics / PK-PD Scientists
PBPK and QSP Modelers
MIDD / Quantitative Sciences Leaders

Extended stakeholders:

Regulatory Affairs professionals supporting model-informed strategies
Translational Medicine and Early Development teams
Clinical Development scientists involved in dose selection and study design
CMC and cross-functional team members involved in bridging or integrated evidence packages

講演者

Eva Berglund, PhD

Vice President, Clinical Pharmacology and Regulatory Strategy

Dr. 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.

長谷川真裕美

Vice President, Clinical Pharmacology

長谷川真裕美（薬学博士）は臨床薬理学，ファーマコメトリクスの分野を中心に18年以上にわたって日本を含むアジア太平洋地域における医薬品開発に携わってきました。

長谷川氏は，がん／免疫，関節リウマチ，心血管系といった治療領域における初期および後期開発プログラムの豊富な経験を有します。これまで米国 FDA，EMA，PMDA を始めとする規制当局との幅広い交渉経験があり，複数の新薬承認申請や臨床薬理関連の照会事項対応を支援しています。専門分野は開発戦略やモデルを活かした医薬品開発（MIDD），免疫原性，バイオマーカーです。

Justin Hay, PhD

Senior Director, Clinical Pharmacology Consulting

Dr. 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.

Lisa Almond, PhD

Senior Director of PBPK Consultancy

Lisa joined Simcyp in 2005, bringing her expertise in predicting pharmacokinetics (PK) and drug-drug interactions (DDIs) while integrating drug and population models within the Simcyp Simulator. Over the past decade, she has been instrumental in helping clients navigate complex drug development challenges with customized PBPK modeling solutions.

With a strong background in infectious diseases, Lisa leads Global Health projects and is committed to advancing PBPK applications for understudied and complex populations, including pregnant and breastfeeding women. Her work focuses on addressing gaps in clinical data, improving drug treatment strategies, and supporting the inclusion of diverse populations in clinical research. She also serves as an Executive Editor for the British Journal of Clinical Pharmacology.

Lisa is known for her collaborative approach and practical, science-driven perspective. She works closely with pharmaceutical and biotech teams on regulatory strategy, DDI assessment, and PBPK applications, including for special populations. Her experience supports informed decision-making across drug development programs.

Racheal Kendrick, PharmD

Senior Director of Clinical Pharmacology and Translational Medicine Certara Drug Development Solutions

Dr. Racheal Kendrick is currently a Senior Director of Clinical Pharmacology and Translational Medicine at Certara. She has 15 years of drug development experience with a focus on quantitative solutions using state of the art methods and software. Racheal has contributed to all phases of the drug development cycle including first in human dose selection, IND support, Phase I study design, strategy, and implementation, dose-finding approaches, exposure-response analyses, and regulatory interactions. Racheal has experience collaborating with teams of scientific professionals from some of the worlds major pharmaceutical and biotechnology companies in many therapeutic areas including neurology, ophthalmology, infectious disease, oncology, hematology, and contraception, advancing both large and small molecules.

Prior to her role at Certara, Racheal was an associate director at a contract research organization, with a focus on Phase I studies. Racheal received her Doctor of Pharmacy from the University of Missouri-Kansas City and completed a pharmacokinetics and pharmacodynamics fellowship with the University of North Carolina and Quintiles.

Model Acceptance in Regulatory Submissions: Practical Strategies for Regulatory Success

概要

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