概述
Clinical pharmacology is being reviewed differently.
With ICH M13A finalized, ICH M15 emerging, and increasing reliance on model-informed evidence, regulators are no longer asking whether studies were conducted, they are asking whether the totality of evidence is credible.
This live, executive-level webinar brings together former FDA, EMA, MHRA, and PMDA clinical pharmacology reviewers to share how regulatory expectations are shifting and where sponsors most often misjudge the line between confidence and concern.
This is not a guidance walkthrough.
It is a strategic conversation about how submissions are actually evaluated heading into 2026.
Attendees will learn how regulators:
- Decide whether to trust model-informed evidence
- Evaluate PBPK, QT, and MIDD strategies under real review pressure profiling
- Interpret global harmonization versus local regulatory nuance
- Assess the CMC–Clinical Pharmacology interface
- Set expectations for clinical pharmacology submissions in 2026 and beyond
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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. 在加入 Certara 之前，她是美国 FDA 临床药理学办公室 CDER 癌症药理学部门的评审员，参与 Project Optimus 下多剂量依据递交的评估工作。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 Consulting, Co-Lead of Certara’s Rare and Neglected Innovation EngineDr. 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.
Paola Coppola, MSc
Director, Clinical Pharmacology and Translational MedicinePaola Coppola is currently Director Clinical Pharmacology at Certara. She has 15+ years of clinical pharmacology and regulatory experience having worked as Senior Pharmacokinetics Assessor at the Medicines and Healthcare products Regulatory Agency (MHRA), UK and in several roles in Industry such as Head of Clinical Pharmacokinetics and Marketed Products Clinical Pharmacology Lead at AstraZeneca, UK, and Pharmacokinetics Scientist in Angelini, Italy. She has been an observer of the EMA PK Working Party and Modelling & Simulation Working Party.
Pyry Valitalo, PhD
Associate Director, PharmacometricsPyry has 15+ years of experience in pharmacometrics across academia, industry, and regulatory settings. He previously served as a clinical pharmacology and pharmacometrics assessor at the Finish regulatory agency.
Mayumi Hasegawa, PhD
Vice President, Clinical PharmacologyDr. Hasegawa 拥有超过 18 年的药物开发经验，专注于临床药理学和定量药理学领域，擅长亚太地区（日本-韩国-中国台湾）的药物开发。
Dr. Hasegawa 在肿瘤/免疫学、类风湿关节炎和心血管等治疗领域的早期和晚期开发项目方面都拥有丰富经验。她拥有与包括 FDA、EMA 和 PMDA 在内的卫生机构进行监管互动的丰富经验，并曾多次支持向全球卫生机构的递交并负责临床药理相关科学问题。她在开发战略、模型引导的药物开发、免疫原性和生物标记物方面拥有特殊专长。
Shalini Yapa, PhD
临床药理学总监Shalini 于 2022 年 8 月加入 Certara。在加入 Certara 之前，她曾在美国 FDA 的炎症和免疫药理学部门担任临床药理学审评员 6 年多，负责一系列治疗领域的工作。她在美国 FDA 批准药物（505(b)(1)/505(b)(2)）、生物制剂（351(a)）和生物类似药（351(k)）产品的过程中积累了丰富的监管经验，涵盖了从 FIH 到上市后研究的药物开发阶段。Shalini 拥有澳大利亚墨尔本莫纳什大学药剂学学位和药学博士学位。她在北卡罗来纳州的北卡罗来纳大学和葛兰素史克公司完成了为期两年的临床 PK/PD 博士后研究。
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