AMWA NorCal Pacific Coast Conference

Conference: AMWA NorCal Pacific Coast Conference

日期： May 15 - 16, 2026

地点： North Carolina Biotech Center. Durham, NC

Transforming drug discovery and development for good

Certara 监管科学服务助您优化申报材料撰写、应对全球监管要求并加速获批进程。From early-stage strategy to post marketing compliance, we ensure the pathway to market is efficient and compliant in any phase.

我们秉持宏伟愿景：to transform your development process and bring greater certainty to regulatory outcomes.

Hear insights from Certara’s experts:

Overcoming the Challenges of Expedited Submission Times with Planning, Top-Down Messaging and Parallel Writing

主讲人： Brenda Taylor, MS

The time being allowed from receipt of last study data to submission of a marketing or new drug application continues to shrink. The demands of planning realistic timelines, maintaining messaging, and writing documents in parallel continues to increase. Efficiency can be obtained through extensive planning, prototyping, and by agreeing on presentation and messaging in the last CSR before draft 1 of the summaries and overviews. Methods for enabling this simultaneous writing of reports, summaries, and overviews will be discussed, including designating the one source of truth. I will also discuss the pros and cons of lockdown meetings and top-down support for the review and approval process.

Brenda Taylor

Director of Global Submissions

Brenda Taylor is a Director of Global Submissions at Certara. She has over 20 years of experience in the biotechnology and pharmaceutical industry. She has led regulatory strategy and submission management activities to support pharmaceutical development and manufacturing, with an emphasis on Initial New Drug (IND) applications and marketing applications. Brenda’s research background in microbiology and immunology includes design and performance of nonclinical studies. Her therapeutic areas of expertise include oncology, cardiovascular, and anti-infective agents, spanning both small-molecule drugs and biologics.

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