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精选资源

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

案例研究

Upcoming regulatory webinars

网络研讨会

RAPS 赞助的网络研讨会：Planning and Preparing Regulatory Submissions Using Top-down Messaging

2025 年 11 月 20 日 – 11:00 EST - 12:00 EST

网络研讨会

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

2025 年 12 月 9 日 – 10:00 am – 10:30 am, Korea time

网络研讨会

Modern SDTM Starts Here: Metadata Management with P21 Enterprise Plus

2025 年 12 月 10 日 – 10:00 – 10:45 am JST

Latest regulatory blogs

博客

Clinical Trials Regulation (EU) No. 536/2014 – The Impact on Annual Safety Reporting

在以下活动中与我们的专家会面

会议

American College of Toxicology 2025 Annual Meeting

November 16 - 19, 2025 – Phoenix, Arizona – Booth 717

会议

PHUSE EU Connect

November 16 - 19, 2025 – Hamburg, Germany

会议

JSCPT 2025 – The 46th Annual Scientific Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics

We’re excited to participate in JSCPT 2025 in Tokyo, The 46th Annual Scientific Meeting of The Japanese Society of Clinical

All regulatory resources

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

网络研讨会

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

Build investor confidence with science-backed strategy

Certara Services, Fact Sheet

Failure to Launch: Building Smarter Strategies to Get the Right Drug to the Right Patient

Certara Services, Drug Development, Webinar

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

Cardiovascular, Certara Services, Clinical Pharmacology, Clinical Trials, Drug Development, Model Informed Drug Development, Model-Based Meta-Analysis (MBMA), Modeling and Simulation - PK/PD, Publication

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

Certara Products - Pinnacle 21, Data Standards, Blog

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

Certara Services, Clinical Trials, Drug Development, Infectious Disease, Model Informed Drug Development, Model-Based Meta-Analysis (MBMA), Modeling and Simulation, Therapeutic Specialties, Publication

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

Discovery - Blog, Blog

Best Practices for AI Prompt Engineering in Life Sciences in 2025

Certara Products, Certara.AI, Blog

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

Certara Services, Clinical Pharmacology, Drug Development, Model Informed Drug Development, Modeling and Simulation, Modeling and Simulation - PBPK, Modeling and Simulation - PK/PD, Modeling and Simulation - QSP, Webinar

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监管审批

最新资源

Certara and ANVISA Partner to Launch eCTD 4.0 Submissions of Drug Applications in Brazil Through GlobalSubmit™ software

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

Certara Study Shows Half of Americans Unaware of FDA/NIH Move to Phase Out Animal Testing of New Drugs

精选资源

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

Upcoming regulatory webinars

RAPS 赞助的网络研讨会：Planning and Preparing Regulatory Submissions Using Top-down Messaging

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

Modern SDTM Starts Here: Metadata Management with P21 Enterprise Plus

Latest regulatory blogs

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

U.S. International Reference Pricing: Global Implications and Pharma Strategy

制定 EMA 政策0070 提交材料的常见问题解答

Clinical Trials Regulation (EU) No. 536/2014 – The Impact on Annual Safety Reporting

在以下活动中与我们的专家会面

American College of Toxicology 2025 Annual Meeting

PHUSE EU Connect

JSCPT 2025 – The 46th Annual Scientific Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics

All regulatory resources

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

Modern SDTM Starts Here: Metadata Management with P21 Enterprise Plus

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

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

Build investor confidence with science-backed strategy

Failure to Launch: Building Smarter Strategies to Get the Right Drug to the Right Patient

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

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

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

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

Best Practices for AI Prompt Engineering in Life Sciences in 2025

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

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