Without careful execution and the ability to navigate unexpected challenges, marketing application submissions are prone to falling off track and costing valuable time and resources… and sleep. In this webcast, you’ll learn best practices for a marketing application submission which can be a significant undertaking. Regulatory experts will offer tips and guidance for acceleration, submission leadership, and regulatory strategy from that you can apply to your marketing application to help ensure a successful submission.
講演者
Demetrius Carter, SVP, Regulatory Services, Synchrogenix, a Certara Company
Demetrius Carter, RAC, is a clinical development executive with 20+ years of drug development experience in both the pharmaceutical and medical device industries. His experience includes roles at Glaxo SmithKline, Pfizer and JNJ before transitioning into the CRO industry. While at IQVIA, Demetrius held roles of increasing responsibilities in project management, clinical monitoring, and central laboratories. He also led global operations at Syneos Health for both the medical device and the oncology business units. Demetrius presently serves as the senior vice president, regulatory services at Synchrogenix where he oversees their regulatory writing, strategy, and operations functions. He has a Bachelor of Science in Biological Sciences from North Carolina State University and an MBA from Fairleigh Dickinson University. He also holds several certifications including Project Management Professional (PMP) from the Project Management Institute, Lean Six-Sigma Green Belt Certification from Villanova University, and the Regulatory Affairs Certification (RAC).
Steve Sibley, VP, Global Submissions and Submission Leadership
Mr. Sibley has more than 30 years of experience in the pharmaceutical industry, with extensive experience in regulatory writing, consulting, and regulatory project leadership. He has successfully supported projects from discovery through approval and life cycle management, including significant roles in more than 75 submissions. In several cases, he lead the entire submission team overseeing all documentation from Modules 1 through 5. In his current role, Mr. Sibley drives the expansion of Sychrogenix’s submission leadership and consulting capabilities in guiding clients to successful clearance of regulatory milestones.
Elaine Taylor, VP, Regulatory Strategy and Policy
Elaine Taylor has more than 30 years of experience in the pharmaceutical industry and has extensive experience in developing and providing strategic guidance and regulatory advice at all stages of product development. She began her career in nonclinical (pharmacology, toxicology) research and then moved to clinical research and regulatory affairs. Ms. Taylor’s specialties include creating innovative and efficient regulatory strategies for drug development, including 505(b)(2) programs, regulatory agency meetings, responses to regulatory agencies, INDs, and marketing applications. In her current role, she provides regulatory strategy, consulting, and submissions support to Synchrogenix customers. Her work has covered many complex therapeutic areas, including endocrine, dermatology, cardiovascular and renal, reproductive, analgesia, arthritis, oncology, gastrointestinal, CNS, and musculoskeletal.
