RAPS（規制関連専門職協会）提供のウェビナー：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. 直近の10年間は、米国食品医薬品局および欧州医薬品庁への数多くの新薬申請、生物製剤承認申請、治験薬（IND）申請をリードしてきました。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. 彼の専門の治療領域には、眼科、神経内科、精神科、慢性疼痛管理分野が含まれます。Mark has an expert understanding of drug discovery and development approaches used in the current biopharmaceutical environment.