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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an On-demand
recording from October 2020.
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.
Intermediate: Content is designed based upon the
assumption that individuals have basic knowledge of the topic(s) and/or
demonstrated competence related to the topic(s). Higher-level concepts are
introduced during lectures; exercises requiring synthesis and/or application of
concepts are incorporated into the activity.
Who Should Attend:
Demetrius Carter, SVP, Regulatory Services, Synchrogenix,
a Certara Company
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
Steve Sibley, VP, Global Submissions and Submission
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
Elaine Taylor, VP, Regulatory Strategy and Policy
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.