日期 2025 年 5 月 28 日
时间 11:00 am to 12:00 pm ET
Services: Regulatory Writing, Regulatory Operations
产品： CoAuthor, GlobalSubmit
概述
Join our exclusive webinar—brought to you by Certara and RAPS—to discover how leading regulatory writing and operations can transform your approach, helping you bring therapies to patients faster while surpassing global compliance standards. This webinar is worth 1 RAC credit.
Accelerate drug approvals in an evolving regulatory world
Is your team ready to drive innovation and stay ahead in the fast-shifting world of drug development?
Senior Director, Regulatory Operations and Clinical Disclosure, Certara
A seasoned pharmaceutical industry veteran, Evans Richardson brings nearly 20 years of experience spanning drugs, biologics, and medical devices. He’s worked with organizations of all sizes, both within industry and at service providers, developing a broad skillset encompassing regulatory affairs and operations, clinical disclosure, quality management, and project management. Currently, he leads a global team of subject matter experts at Certara, helping clients navigate electronic regulatory submissions and clinical data disclosure requirements.
Senior Director, Global Submissions, Certara
Bowlby 博士在临床研究和药物开发行业拥有超过 25 年的经验。在过去的 10 年中，他领导了许多新药申请、生物制品许可申请和向美国食品药品监督管理局和欧洲药品管理局提交的研究性新药 (IND) 申请。Bowlby 博士领导了研究者手册 (IB)、临床研究报告 (CSR)、临床总结和概述、简报和其他监管文件的编写。在他职业生涯的早期，Bowlby 博士有计划地撰写了大量关于他在哈佛医学院的科学研究和博士后工作的生物医学手稿、海报和幻灯片。他的专业治疗领域包括眼科、神经病学、精神病学和慢性疼痛。Bowlby 博士对当前生物制药环境中使用的药物发现和开发方法有着专业的认识。
