概要
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. 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.
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.
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。
Shalini Yapa, PhD
臨床薬理学担当シニア・ディレクター, サターラ オーストラリアShaliniは2022年にサターラに入社しました。入社前は、米国 FDA の臨床薬理学審査官として、炎症・免疫薬理学部門にてさまざまな治療分野の承認審査を 6年以上担当しました。医薬品（505(b)(1)/505(b)(2)）、生物製剤（351(a)）、バイオシミラー（351(k)）製品のFIHから市販後試験までの医薬品開発に関して、米国FDA承認プロセスに精通しています。Shaliniはモナシュ大学で薬学の学位と薬学博士号を取得しました。ノースカロライナ州のUNCとGSKで2年間の臨床PK/PDポスドクを修了しています。
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