Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations

日期： 2026 年 5 月 5 日, 星期二

时间： 11am ET - 12pm ET

Services: Clinical Pharmacology and Translational Medicine, Pharmacometrics , Pharmacometrics Strategic Regulatory Affairs Consulting, Modeling and Simulation, Quantitative Systems Pharmacology Consulting

产品： Phoenix® NLME, Simcyp® PBPK Simulator, Certara IQ™

概述

The finalization of the ICH M15 guideline marks a pivotal moment for Model-Informed Drug Development (MIDD). For the first time, global regulatory authorities have established a harmonized framework for assessing credibility, validation, documentation, and regulatory application of modeling and simulation.

More importantly, ICH M15 signals a shift in how modeling is used, not as a standalone analysis, but as a strategic, decision-enabling framework across the entire drug development lifecycle.

In this webinar, Certara experts across regulatory strategy, clinical pharmacology, pharmacometrics, Quantitative Systems Pharmacology (QSP), and modeling technologies will explore how sponsors can operationalize MIDD in alignment with ICH M15. The discussion will focus on how to connect modeling approaches, regulatory expectations, and decision-making, from early development through global submission, into a cohesive and impactful strategy.

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What we’ll cover

Model credibility and regulatory decision-making
How ICH M15 defines credibility in the context of use, decision impact, and regulatory risk
Designing an end-to-end MIDD strategy
Embedding modeling into clinical pharmacology and regulatory strategies across the development lifecycle
MIDD in practice: case-based insights
How integrated modeling approaches (PopPK, PK/PD, PBPK, QSP, MBMA) inform key development decisions through real-world application
Integrated modeling for decision-making
How modeling approaches collectively support dose selection, trial design, labeling, and benefit–risk assessment
Regulatory frameworks and considerations
Context of use, uncertainty in mechanistic models, EMA qualification pathways, Bayesian approaches, and alignment with emerging guidance such as ICH E21
Enabling MIDD with modern platforms
How modern tools guide modelers to the appropriate model, support objective model selection across the full model space, and ensure reproducibility through code-based workflows and GUI-to-code translation

Why it matters

ICH M15 raises expectations but also creates opportunity. Sponsors who can clearly demonstrate how models inform decisions will be better positioned to reduce uncertainty, streamline development, and strengthen regulatory confidence.

When applied effectively, MIDD becomes the connective framework that links data, models, and decisions, driving more efficient and informed drug development.

By attending, participants will:

Understand how to align end-to-end MIDD strategies with ICH M15 expectations
Learn how regulators assess model credibility in the context of decision impact and risk
Gain a practical framework for implementing MIDD across the drug development lifecycle
See how integrated modeling approaches strengthen decision-making and regulatory submissions
Explore best practices for generating reproducible, regulator-ready modeling evidence
Understand the expanding role of QSP and mechanistic modeling in development and regulatory decision-making

Who should attend

This webinar is designed for professionals involved in drug development and regulatory strategy who are looking to apply modeling and simulation more effectively across the development lifecycle.

Clinical pharmacology, pharmacometrics, and modeling experts
Regulatory affairs and regulatory strategy professionals
Clinical development and translational science leaders
Scientists and teams applying PBPK, PK/PD, or QSP approaches
R&D and drug development decision-makers

Ideal For Organizations

Pharmaceutical and biotechnology companies
Contract research and development organizations (CROs/CDMOs)

Best Fit for Those Who

Are integrating Model-Informed Drug Development (MIDD) into their programs
Are preparing for or supporting regulatory submissions
Want to align with evolving global expectations such as the ICH M15 guideline
Are making strategic decisions across Phase 1–3 development

演讲嘉宾：

Eva Berglund, PhD

Senior Director, 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.

Paul Matthias Diderichsen

VP Regional Lead Europe/Africa, Quantitative Science Services

Paul is a leader in model-informed drug development, with deep expertise in population PK, PK/PD, exposure–response, QTc, and model-based meta-analysis, supporting global drug development strategy, study design, and regulatory success.

Keith Nieforth 博士

定量药理学软件高级主任

Nieforth 博士是 Certara 的定量药理学软件高级主任，在拥有逾 20 年的全球药物开发经验。在入职 Certara 之前，Nieforth 博士曾在 Roche 的临床药理学部门担任各种职务，从直接的项目支持角色（支持成功的新药上市申请），乃至入选全球临床药理学领导团队（作为部门的系统专家）。
除了在药物开发的定量和系统方面具有专业知识外，Nieforth 博士还热衷于了解和优化成功系统实施中关于人的方面。Keith 持有康涅狄格大学药学理学士学位，以及麻省药科与健康科学学院药学博士学位。

Karen Rowland Yeo, PhD

高级副总裁，客户与监管战略部

Karen is Senior Vice-President, Client & Regulatory Strategy at Certara UK Limited’s Simcyp Division. Prior to this, she was the Head of PBPK Consultancy Services at Simcyp where she led a team of scientists engaged in Consultancy projects relating to the application of physiologically based pharmacokinetic (PBPK) modelling in drug development. Her work has focused on the use of PBPK models for assessment of drug-drug interactions and dosing of special populations and she is the author/co-author of more than 100 peer reviewed articles in these areas.

Piet van der Graaf

Senior Vice President and Head of Quantitative Systems Pharmacology

Piet van der Graaf, PharmD, PhD is Senior Vice President Applied BioSimulation at Certara, Professor of Systems Pharmacology at Leiden University, and Professor of Pediatrics at Cincinnati Children’s Hospital Medical Center. Previously, he was the Director of the Leiden Academic Centre for Drug Research and held leadership positions at Pfizer in Discovery Biology, DMPK and Clinical Pharmacology. Piet 于Pharmacometrics & Systems Pharmacology before becoming Editor-in-Chief of Clinical Pharmacology & Therapeutics. Piet 曾在伦敦国王学院师从诺贝尔奖获得者 Sir James Black，接受了临床医学的博士培训。He was awarded the 2024 Gary Neil Prize for Innovation in Drug Development from the American Society of Clinical Pharmacology and Therapeutics (ASCPT) and the 2021 Leadership Award from the International Society of Pharmacometrics (ISoP). Piet 是英国药理学会的当选委员，在定量药理学和药物开发领域发表了超过 250 篇同行评议的论文。