Summary
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 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 has over 18 years of drug development experience focused on the areas of clinical pharmacology, pharmacometrics and specializes in development for Asia Pacific regions (APAC; Japan-Korea-Taiwan).
Dr. Hasegawa has experience in both early and late development programs across therapeutic areas of Oncology/Immunology, Rheumatoid Arthritis and Cardiovascular. She has extensive regulatory interaction experience with health authorities including FDA, EMA and PMDA and has supported multiple filings and accountability for Clin Pharm-related scientific issues with global health authorities. She has special expertise in development strategy, Model Informed Drug Development, immunogenicity and biomarkers.
Shalini Yapa
Director, Clinical PharmacologyShalini joined Certara in August 2022. Prior to joining Certara, she was a Clinical Pharmacology reviewer for 6+ years at the U.S. FDA working on a range of therapeutic areas in the Division of Inflammation and Immune Pharmacology. She has extensive regulatory experience in the U.S. FDA approval process for drugs (505(b)(1)/505(b)(2)), biologics (351(a)), and biosimilar (351(k)) products spanning the range of drug development from FIH to post-marketing studies. Shalini has a degree in Pharmacy and a PhD in Pharmaceutical Sciences from Monash University in Melbourne, Australia. She completed a 2-year clinical PK/PD postdoctoral fellowship at UNC and GSK in North Carolina.
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