Certainty Japan 2026

Date: Tuesday, June 23, 2026

Time: 9:30am – 4:45pm

Location: Shinagawa, Tokyo

Certainty by Certara provides valuable opportunities to connect you with industry leaders and modeling & simulation (M&S) experts. Certara’s experts and guest speakers present the latest regulatory updates, applied case studies, and the cutting-edge technologies including AI/ML related to Model-informed Drug Development, clinical pharmacology, Pharmacometrics, QSP, PBPK, and more.

As a new feature in 2026, the afternoon agenda will include breakout sessions on (1) Modeling & Simulation Updates and (2) Discovery and Toxicology Assessment. Attendees will select one session during registration.

We hope this annual event will help you connect with innovative researchers across various pharmaceutical companies and bring the innovations to your team.

Overview

Date & Time: 9:30am – 4:45pm, Tuesday, June 23rd
Reception desk opens at: 9:00am
Venue: TKP Garden City PREMIUM Shinagawa Takanawa, 3rd floor
Registration fee: Free of charge

Register now

Agenda

Speakers’ biography (PDF): Coming soon
Timetable with speaker information (PDF): Coming soon

Morning Plenary Sessions for All Attendees

Global MIDD Regulatory Landscape: FDA & EMA Updates

Modeling & Simulation approaches used for regulatory submissions

QSP latest case studies across all development phases and regulatory

Strategy First: Translational modeling from preclinical to clinical - Case studies of FIH dose justification

Digital Data Flow (DDF) from 3D to 4D

Afternoon Breakout Sessions

Track 1: Modeling & Simulation Updates and Case Studies

MIDD strategies to overcome clinical pharmacology challenges for regulatory approvals - Case studies of dose justification in late phase

[Guest Speaker] Pediatric drug development: current landscape, challenges, and future directions
Chie Emoto, PhD, Chugai Pharmaceutical Co., Ltd/ Laboratory of Drug Metabolism and Pharmacokinetics, Showa Pharmaceutical University

[Guest Speaker] Reaching the Unreached: Accelerating Value Creation in Rare Disease Drug Development Through Australia
Juran Kato, PhD, President & CEO, GEXVal

[Guest Speaker] Regulatory experience with PBPK in DDI evaluation of a novel TROP2-directed antibody-drug conjugate, DATROWAY
Akiko Watanabe, PhD, Daiichi Sankyo

Optimal dosing, optimal outcomes: PBPK case studies for ADCs

Track 2: AI-Enabled Discovery & Candidate Assessment

Enabling AI-driven Modeling and Simulation-based Decision making in Discovery Towards Increased Clinical Drug Candidate Success

Deep Learning in Discovery

Safety First: Uncovering the Clinical Risks Inside Your Compound Screening Data

Why QSP for Drug Discovery - Early feasibility for asset viability

Session for AI-enabled Discovery or Candidate Assessment is coming soon

Guest speakers

*Order of presentations

Chie Emoto, PhD

Group Manager of System Pharmacology group, Translational Research Division, Chugai Pharmaceutical Co., Ltd/ Laboratory of Drug Metabolism and Pharmacokinetics, Showa Pharmaceutical University

Session: Pediatric drug development: current landscape, challenges, and future directions