RAPS 赞助的网络研讨会：From Silos to Synergy: A Practical Guide to Integrating Regulatory Writing and Operations for Seamless Submissions

Evan Richardson began his career in the pharmaceutical industry 18 years ago, and today he is the senior director of transparency and disclosure services at Certara. His experience includes drugs, biologics, and medical devices and he has worked for both service providers and in industry across organizations of all sizes. Evan has worn many hats throughout his career, including roles in regulatory affairs, regulatory operations, quality management, and project management. In his current role, Evan leads a global team of subject matter experts supporting Certara’s clients in meeting their regulatory requirements for the disclosure of clinical data.

Mark Bowlby, PhD, has over 25 years of experience in the clinical research and drug development industry. 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。Mark has led the authoring of Investigator’s Brochures (IBs), clinical study reports (CSRs), clinical summaries and overviews, briefing packages, and other regulatory documents. Earlier in his career, Mark planned and wrote numerous biomedical manuscripts, posters, and slides regarding his scientific research and postdoctoral work at Harvard Medical School. 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。Mark has an expert understanding of drug discovery and development approaches used in the current biopharmaceutical environment.