RAPS Sponsored Webcast: Regulatory Writing and Operations to Accelerate Submissions

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

Dr. Bowlby has over 25 years of experience in the clinical research and drug development industry. During the last 10 years, he has led many New Drug Applications, Biologics License Applications, and Investigational New Drug (IND) submissions to the Food and Drug Administration and European Medicines Agency. Dr. Bowlby 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, Dr. Bowlby planned and wrote numerous biomedical manuscripts, posters, and slides regarding his scientific research and postdoctoral work at Harvard Medical School. His therapeutic areas of expertise include ophthalmology, neurology, psychiatry, and chronic pain. Dr. Bowlby has an expert understanding of drug discovery and development approaches used in the current biopharmaceutical environment.