Professor Earl W. Hulihan
Oxford Who’s Who has inducted Professor Earl W. Hulihan into the highest Professional Distinction “Top Tier of Excellence Lifetime Achievement Recognition” due to his outstanding contributions and achievements in the field of national as well as international health care consulting. Throughout his career, Professor Hulihan has been self-motivated, results oriented and driven to succeed. With five decades of professional experience, Professor Hulihan has honed his expertise in medicine, pharmaceuticals and teaching. He now utilizes his experience and expertise in his role as principal consultant of Professor Earl W. Hulihan Consultancy. Professor Hulihan provides health care compliance advice and consultation to regulatory authorities, and the pharmaceutical, biotech and device industries. He partners with regulators in training to ensure that the industry is in compliance with applicable international regulations and guidelines through quality initiatives, such as internal and external compliance audits, training workshops and consultations. His further responsibilities include assisting clients with development, implementation, and oversight of internal and external quality management systems to meet or exceed their corporate quality goals, regulatory requirements and industry expectations. Professor Hulihan one of the few special honorees inducted into the highest professional distinction based on his accomplishments, academic achievements, years of service, and the credentials he has provided. Professor Hulihan currently works with regulatory authority personnel in 16 countries in North American, Latin American, European and Asia-Pacific communities. For several years now, Professor Hulihan has been recognized as an "expert in his field" as well as a "scientific expert" by several regulatory authorities. Professor Hulihan continues to provide advice and training to regulatory authority personnel within the North American, Latin American, European and APAC communities. This multi-national, "regulatory trust in his knowledge, experience and integrity" is unique in this industry. Oxford Who’s Who proudly endorses Professor Earl W. Hulihan for he truly is an Iconic force.
Currently, at the expressed written invitation of senior management of the China Food and Drug Administration, Professor Hulihan is conducting two weeks of intensive training workshops for CFDA field inspectors and industry representatives on topics such as ICH Q8, Q9 and Q10, Good Documentation Practices, ISO Standards and other relevant regulations. Additional sessions include; e--diagnostics, process controls, HVAC, water systems, personnel/training records management, waste processing, labeling/packaging and records management including: master production records, proper batch records, distribution records, stability records, and lot release records. In addition to working in this capacity, Professor Hulihan maintains active professorships at Rutgers University Medical School and the University of Shanghai Medical School. In June 2015, he was reappointed associate professor in the Department of Health Informatics in the School of Health Related Professions at Rutgers, the State University of New Jersey. Prior to establishing his consultancy firm, Professor Hulihan served as senior vice president of regulatory affairs at Medidata Solutions Worldwide, and held the positions of senior vice president, regulatory consulting services in several internationally known regulatory consulting firms. His work with these internationally recognized GxP consulting firms involved providing regulatory consulting, auditing, and training services to the global pharmaceutical, biologics, and medical device industries. Professor Hulihan has over 40 successful years of experience in the global GxP regulatory environment, specializing in the areas of quality assurance, regulatory affairs, clinical research, drug development, drug safety and quality systems. He has held senior quality assurance positions in the global pharmaceutical environment, and he has spent more than 31 concurrent years in clinical medicine and clinical research at the University of Medicine and Dentistry of New Jersey. His clinical areas of involvement included cardiovascular, pulmonary, and endocrine areas of medicine, as well as psychiatry. A skilled public speaker and writer, Professor Hulihan has been invited to speak and serve as chair at many industry conferences worldwide. He is a contributing author and co-editor to several medical textbooks, and he has authored numerous journal articles during his career. Professor Hulihan believes that his success stems in part from the education and desire to achieve received at Cheltenham School District and East Stroudsburg University of Pennsylvania (ESU). In June of last year, Professor Hulihan was appointed to the ESU Alumni Association's Board of Directors for a three-year term of office. During his formative years, Professor Hulihan was significantly influenced by the input of two mentors: Dr. Hans Kraus and Peter Kuo. Dr. Kraus was influential in starting the President's Council on Physical Fitness, and was one of John F. Kennedy's personal health care specialists. Dr. Kraus allowed Professor Hulihan to study alongside him for many years and learn a great deal about medicine in the process. Dr. Kuo was a world-renowned cardiologist, who also mentored Professor Hulihan a great deal of their time as they worked together at UMDNJ. Professor Hulihan's extensive academic foundation includes a Master of Education from East Stroudsburg University of Pennsylvania, where he specialized in the areas of health and physical education, curriculum development, educational psychology, research design, and teaching methodology. He completed a kinesiology and applied anatomy internship through New York University, as well as advanced training in physiology and cardiopulmonary physiology. In 1971, he earned a Bachelor of Science in health education and a Bachelor of Science in physical education. Mr. Hulihan holds teaching certifications in the states of Pennsylvania and New Jersey. He has remained current in his field over the years through affiliations with a multitude of professional associations, including the Drug Information Association, the American Heart Association and the Regulatory Affairs Professional Society. Professor Hulihan's efforts have not gone without formal recognition; his Professorships in China are the first ever extended to a 'Westerner', and most recently, he received a distinguished alumni award from East Stroudsburg University. The Distinguished Alumni Award honors an alumna or alumnus whose exceptional achievements, experiences or contributions in a field or profession have distinguished themselves on the national or international level. The recipients of this award possess the highest standards of integrity and character to positively reflect and enhance the prestige of the university. This award is the highest honor an ESU alumna/us can receive. Looking toward the future, Mr. Hulihan will continue staying current in the industry so that he can improve the quality of life for patients.