Christian Apfel, M.D., Ph.D.
Dr. Apfel is the Executive Director of Strategic Statistics and Study Design for NEMA and oversees all aspects of operations for Regulatory Affairs and QA/Compliance functions in support of corporate initiatives and the clinical project management/operations team. He provides guidance, oversight, and strategic planning to ensure regulatory compliance and support the successful completion of clinical trials. He is responsible for implementing new FDA regulations affecting clinical trial conduct and the corporate responsibility associated with clinical trials and regulatory dossiers, and advises staff on appropriate action in the event of non-compliance issues. Dr. Apfel has 15 years of professional experience in the drug development, clinical research, healthcare, and wellness industries. He has worked in regulatory affairs for two global CROs served as a consultant for various biopharmaceutical and medical device companies. Dr. Apfel is an internationally recognized expert and strategic statistical analysis and a nationally and internationally recognized Key Opinion Leader with more than 75 peer reviewed publications in top journals, including the New England Journal of Medicine. Academically connected and recognized for visionary leadership and strategic directions that have changed clinical practice. He has clinical research and project management experience including clinical trial design, protocol development, budget and resource management, staff recruitment and training, laboratory management, GCP compliance, patient recruitment and data collection for FDA approval, statistical analyses and manuscript preparation.