Home / Resources / Regulatory resources

监管审批

最新资源

Merck Advances Pediatric Oncology with Innovative ADC Modeling

Merck Advances Pediatric Oncology with Innovative ADC Modeling

How to build standardized eCRFs across multiple EDC systems

How to build standardized eCRFs across multiple EDC systems

New Approach Methodologies (NAMs): By the numbers

New Approach Methodologies (NAMs): By the numbers

Fact Sheet, Guide

精选资源

7 key annotated CRF regulatory submission requirements you should know

7 key annotated CRF regulatory submission requirements you should know

Upcoming regulatory webinars

网络研讨会

AAPS Webinar – Pediatric Drug Development: Why It’s Critical to Submission Strategy and How Modeling, Regulatory, and Clinical Insights Shape Success

2026 年 1 月 13 日 – 12:30 pm to 1:30 pm EST

网络研讨会

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

2026 年 1 月 27 日 – 10:00am – 10:30am Japan time

Latest regulatory blogs

How to build standardized eCRFs across multiple EDC systems

7 key annotated CRF regulatory submission requirements you should know

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

How To Design a Case Report Form | 7 Best Practice Steps

Not Just Another ChatGPT: Why Life Sciences Needs Domain-Specific AI

Best Practices for AI Prompt Engineering in Life Sciences in 2025

在以下活动中与我们的专家会面

JPM 2026 44th Annual Healthcare Conference & Biotech Showcase

January 12 - 16, 2026 – San Francisco, CA

ICoP 2026 India

January 28 - 31, 2026

DIA RSIDM 2026

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

All regulatory resources

Merck Advances Pediatric Oncology with Innovative ADC Modeling

Biologics, Certara Services, Clinical Pharmacology, Clinical Trials, Drug Development, Drug Safety, Model Informed Drug Development, Modeling and Simulation, Modeling and Simulation - PBPK, Modeling and Simulation - QSP, Oncology/Hematology, Pediatrics, Therapeutic Specialties, Case Study

How to build standardized eCRFs across multiple EDC systems

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

ICoP 2026 India

Certara Products - Simcyp, Certara Services, Clinical Pharmacology, Drug Development, Model Informed Drug Development, Modeling and Simulation, Modeling and Simulation - PBPK, Modeling and Simulation - QSP, Conference

New Approach Methodologies (NAMs): By the numbers

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

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

Certara 产品，网络研讨会

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]

网络研讨会点播

Modern SDTM Starts Here: Metadata Management with P21 Enterprise Plus

Certara Products - Pinnacle 21, Data Standards, On-Demand Webinar

1
2
3
……
32
›

订阅时事通讯

为什么订阅？因为改变药物开发不仅是我们的目标，更是我们的执着追求。如果这也是您的想法，那么请第一时间了解新见解，与我们一起推动科学发展。

© 2025 Certara. 保留所有权力。 | 法律 | 隐私政策

沪ICP备2022021526号

Powered by Translations.com GlobalLink Web Software