Jim Gallagher

Case Study

Strategic Planning and technology to support a rolling BLA submission under tight timelines

A Tier 3 Sponsor called upon Certara to support its rolling BLA submission, the second…

Jim Gallagher2021 年 7 月 19 日

On-Demand Webinar

开源建模工具：火上浇油 vs. 平息争论

The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing…

Jim Gallagher2021 年 7 月 15 日

Case Study

Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta

Many cystic fibrosis (CF) patients take several medications at one time to manage symptoms and…

Jim Gallagher2021 年 7 月 14 日

Case Study

治疗镰状细胞病的 Voxelotor：无需任何临床研究，利用剂量预测模型进行 DDI 预测

In November 2019, the US FDA granted accelerated approval for Oxbryta™ (voxelotor) tablets for the…

Jim Gallagher2021 年 7 月 14 日

Video

会见 Certara 监管运营专家

Meet Rachel Bombara, Sr. Regulatory Operations Specialist at Certara. In this brief video Rachel shares…

Jim Gallagher2021 年 7 月 2 日

Case Study

针对复杂的患者资料和病例叙述的模板的需求

A global pharmaceutical company came to Certara to generate both patient profile (PPL) and narrative…

Jim Gallagher2021 年 6 月 24 日

Article

Fundamentals of regulatory writing: the document development process

Regulatory writers lead the development of high-quality regulatory documents by working incollaboration with colleagues across…

Jim Gallagher2021 年 6 月 22 日

Brochure

推动具有影响力的科学成果从实验室走向市场

Learn how Certara drives impactful science.

Jim Gallagher2021 年 6 月 14 日

On-Demand Webinar

Three Pathways have emerged in Innovative Access Agreements

The days of simply determining the market demand for a new drug as a function…

Jim Gallagher2021 年 6 月 11 日

On-Demand Webinar

Outcomes Based Agreements

The days of simply determining the market demand for a new drug as a function…

Jim Gallagher2021 年 6 月 11 日

Jim Gallagher

Strategic Planning and technology to support a rolling BLA submission under tight timelines

开源建模工具：火上浇油 vs. 平息争论

Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta

治疗镰状细胞病的 Voxelotor：无需任何临床研究，利用剂量预测模型进行 DDI 预测

会见 Certara 监管运营专家

针对复杂的患者资料和病例叙述的模板的需求

Fundamentals of regulatory writing: the document development process

推动具有影响力的科学成果从实验室走向市场

Three Pathways have emerged in Innovative Access Agreements

Outcomes Based Agreements

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