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Latest resources

Featured resource

Upcoming regulatory webinars

Latest regulatory blogs

Meet our experts at the following events

Conference

JPM 2026 44th Annual Healthcare Conference & Biotech Showcase

January 12 - 16, 2026 – San Francisco, CA
Conference

DIA RSIDM 2026

February 2 - 4, 2026 – Bethesda North Marriott Hotel & Conference Center, North Bethesda, MD – Booth 202
Conference

PHUSE APAC Connect 2026

February 19 - 21, 2026 – Hyderabad, India

All regulatory resources

Implementing AI in Medical Writing: Prepare Today for Tomorrow’s Efficiency [Japanese Webinar]

Certara Products, Webinar

7 key annotated CRF regulatory submission requirements you should know

CDISC, Certara Products - Pinnacle 21, Data Standards, Blog

Expedited Pharmacometrics Regulatory Submissions

Clinical Pharmacology, Clinical Trials, Model Informed Drug Development, Modeling and Simulation, Fact Sheet

History and Evolution of Innovations in Clinical Pharmacology

Clinical Pharmacology, Model Informed Drug Development, Modeling and Simulation, Publication

The Proposed Food and Drug Administration (FDA) Development Safety Update Report (DSUR) Guidance

Certara Services, Blog

PHUSE APAC Connect 2026

Certara Products - Pinnacle 21, Clinical Trials, Data Standards, SDTM, Conference

The Next Chapter: What Generative AI Means for Medical Writers [Korean Webinar]

Webinar

Modern SDTM Starts Here: Metadata Management with P21 Enterprise Plus

Certara Products - Pinnacle 21, Data Standards, Webinar

Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema

Certara Services, Clinical Pharmacology, Drug Development, Model Informed Drug Development, Modeling and Simulation - PK/PD, Pharmacometrics, Rare and Neglected Diseases, Therapeutic Specialties, Publication

Validation in clinical data management: MacroGenics® Optimizes Validation and Issue Management with Pinnacle 21® Enterprise

Certara Products - Pinnacle 21, Oncology/Hematology, Case Study

New Approach Methodologies (NAMs): By the numbers

Certara Services, Modeling and Simulation, New Approach Methodologies (NAMs), Fact Sheet, Guide

Model-Informed Drug Development (MIDD) as a tool to Enhance Asset Value and Address Key Investor Concerns

Clinical Pharmacology, Drug Development, Model Informed Drug Development, Modeling and Simulation, Modeling and Simulation - PBPK, Modeling and Simulation - PK/PD, On-Demand Webinar
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