Biography
Edward Greg Koski is a Co-Founder, President and CEO of Alliance for Clinical Research Excellence and Safety. Internationally-recognised leader in clinical research championing a systemic approach to transforming the infrastructure and ecosystem for conducting clinical research globally; and a "culture of conscience" in human research, focusing on prevention of harm and quality improvement beyond regulatory compliance.First Director of Office for Human Research Protections (OHRP) at U.S. Department of Health and Human Services; created Program for International Activities within OHRP. Consultant to World Health Organization (WHO) to coordinate and strengthen global mechanisms for ethical conduct of human research; and engaged with World Medical Association (WMA) on revisions of the Declaration of Helsinki. Faculty: Harvard Medical School, Boston University School of Medicine, Vienna (Austria) School for Clinical Research; guest lecturer at more than 100 academic institutions globally, including Rockefeller University, UCSF, Emory, Wayne State, Beijing University, Columbia, University of Chicago, Royal College of Physicians. Keynote speaker at Conferences across Europe, Latin America, and Asia.
Research Interest
Biography
Lee Truax-Bellows is a Founder, President and CEO of Norwich Clinical Research Associates Ltd. (NCRA). NCRA is a full service clinical contract research organization (CRO) based in upstate NY. She has an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO as a Monitor, Medical Communications Associate, Project Manager, Senior Quality Auditor, GCP Trainer, and Regulatory and SOP Consultant. She has been involved in regulated research the past 25 years and currently specializes in product development, GCP auditing, and SOP development and training on regulated research and Good Clinical Practice. She is an active member of the Association of Clinical Research Professionals (ACRP), New York State MedTech Association and Society of Quality Assurance (SQA). She is ACRP certified as a Certified Clinical Research Associate (CCRA) and registered through SQA as a Registered Quality Assurance Professional in Good Clinical Practices (RQAP-GCP).
Research Interest
Biography
Michael is Vice President of Global Compliance and Risk Management at Clinical Supplies Management, Inc. Michael is responsible for the oversight of CSM's global compliance, risk management, process excellence and quality programs. Michael has over 28 years of Compliance experience in the pharmaceutical industry. Prior to joining CSM, Michael held various R&D, Manufacturing and Global Compliance positions during his 26-years at Merck & Co. Inc.
Research Interest