International Conference on Clinical Trials July 27-29, 2015 Orlando-FL, USA

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.

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).

James J. Hickman is the Founding Director of the NanoScience Technology Center and a Professor of Nanoscience Technology, Chemistry, Biomolecular Science, Physics, Material Science and Electrical Engineering at the University of Central Florida. Previously, he held the position of the Hunter Endowed Chair in the Bioengineering Department at Clemson University. Dr. Hickman has a Ph.D. from the Massachusetts Institute of Technology in Chemistry, as well as BS and MS from Penn State University in Chemistry. For the past twenty-five years, he has been studying the interaction of biological species with modified surfaces, first in industry and in the latter years in academia. While in industry he established one of the first bioelectronics labs in the country that focused on cell-based sensors and their integration with electronic devices. He has extensive experience in surface modification and surface analysis for biological and neuroscience applications, and the integration of these systems with MEMS devices and components for human body-on-a-chip applications. He is also the founder and current Chief Scientist of a biotechnology company, Hesperos, that is focusing on cell-based systems for drug discovery and toxicity. He has 110 publications and 18 book chapters, in addition to 26 patents.

Noémi Császár Nagy: Work experience 1994 - 1997: Occupation or position held Post-gradual scholar (Academic Research and Education), Main activities and responsibilities- Education and research 1998 – 2006: Occupation or position held- Psychologist, Main activities and responsibilities- Psychological diagnostics and therapy 2000 - 2010: Occupation or position held- Academic Lecturer, Docent (Associate Professor), Main activities and responsibilities- Education 2006 → Occupation or position held- Leader Psychologist, Head of Psychotherapy Department, Main activities and responsibilities- Department Leading, Supervision 2010 → Occupation or position held- Psychologist, Manager, Main activities and responsibilities Leading of the Psychosomatic Ambulance Kft, Supervision Education and training: 1988 – 1994: Title of qualification awarded- Psychologist, Name and type of organization providing education and training, Eötvös Loránd Science University, Department of Psychology (University) 1994 – 1997: Title of qualification awarded- PhD Behavioral Sciences, Principal subjects / occupational skills covered Behavioral Sciences, Empirical Psychology, Differential Psychology, Hypnosis, Name and type of organization providing education and training- School of Psychological Ph.D. Studies, Eötvös Loránd Science University 1996 – 1998: Title of qualification awarded Hypnotherapist (Trainer-Hypnotherapist), Name and type of organization providing education and training, Hungarian Association of Hypnosis 2002 – 2004: Title of qualification awarded- Psychotherapist, Name and type of organization providing education and training Psychosomatic and Psycho-therapeutic Department of National Rehabilitation Institute of Tündérhegy 2006–2009: Title of qualification awarded, Expert Witness in Adult Clinical Psychology 2007 – 2011: Title of qualification awarded, TANDEM Hypnotherapist, Principal subjects / occupational skills covered Training in Trans-natal (TANDEM) Hypnosis, Name and type of organization providing education and training Hungarian Association of Hypnosis

Adnan Qureshi is a Professor of Neurology, Neurosurgery and Radiology and Program Director of the Endovascular Surgical Neuroradiology Program at the University of Minnesota. His practice is primarily affiliated with the University of Minnesota Medical Center, Fairview where he is Director of Interventional and Endovascular Procedures. He currently serves as President of the International Society of Interventional Neurology as well as Executive Director of the Minnesota Stroke Initiative. Adnan Qureshi is also the Associate Head of the Department of Neurology at the University of Minnesota.

Adnan Qureshi's research interests include the acute treatment of hypertension in stroke, the endovascular treatment of ischemic stroke, and the treatment of intracerebral hemorrhage.

Dr. Qureshi is the Medical Director of the Health Sciences Division at PSI INTERNATIONAL Inc. Her responsibilities include directing all client support activities and keeping abreast of issues and trends related to pharmacovigilance worldwide. She is also responsible for supporting the development of corporate strategies for technical investments, client support and strategic alliances. She is a physician and is also pursuing an advanced degree in Regulatory Science at the prestigious Johns Hopkins University Dr. Qureshi’s assignment to both federal and commercial projects in support of drug safety have made her proficient in performing drug-related risk assessment and risk intervention support. She has developed outstanding capabilities in her positions as a medical director, manager, risk management specialist, and trainer at PSI INTERNATIONAL, Inc. She also is an expert in various dictionaries, including the Medical Dictionary for Regulatory Activities (MedDRA), the World Health Organization Drug Dictionary (WHO-DD) and International Classification of Disease (ICD 9/10). She has supported Pharmacovigilance activities at a senior level with over 20 pharmaceutical clients, the World Health Organization- Uppsala Monitoring Center as well as the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Adverse Events Reporting Programs Support; National Institutes of Health (NIH); and at U.S. Army Medical Materiel Development Activity (USAMDA) providing training to data management staff; She frequently attends conferences at the Institute of Medicine and the National Science Foundation on subjects such as Sentinel and various Electronic Health Information related initiatives in government and industry.

Galya Naydenova Atanasova completed her Ph.D. training in Cardiology from Department of Cardiology, Pulmonology and Endocrinology at Pleven Medical University, Bulgaria. She is a General Practitioner and Cardiologist in Trainee at Pleven Medical University, Bulgaria. She specialized in General Medicine from Pleven Medical University, Bulgaria during 1993. She has attended to many International Events and presented her research work. She did many researches on metabolic syndrome and myocardial infarction of heart.

Ayman M. Noreddin received his Ph.D. in pharmaceutical Sciences from the University of the Pacific, California and received research training as a visiting scholar at the Department of Medicine, Stanford University. He had postdoctoral fellowship (Pharmacokinetics and Pharmacodynamics of Antimicrobials), Department of Medical Microbiology, University of Manitoba followed by an American College of Clinical Pharmacy postdoctoral fellowship (Infectious Diseases). Noreddin’s research interest includes Pharmacoklinetic/Pharmacodynamic modeling of anti-infective and anti-cancer therapy, clinical simulation and Monte Carlo analysis and bacterial resistance in biofilm studies. Noreddin has outstanding records of scientific and academic accomplishments with multiple research funding, numerous publications in highly prestigious journals and various presentations in both national and international conferences. He served as a scientific reviewer for the NIH as well as other national and international research institutions

1. Pharmacokinetic/Pharmacodynamic modeling of anti-infective and anti-cancer therapy 2. Clinical simulation and Monte Carlo analysis 3. Bacterial resistance in biofilm studies 4. Cancer epigenetic studies 5. Minority health care studies

Arun Aggarwal received his Ph.D. in 2004 from the University of Sydney. He is currently working as a Visiting Neurologist at Concord hospital, a Chronic Pain Specialist at the RPAH Pain Clinic and a Rehabilitation Specialist at Balmain hospital. He is a member of the Royal Australasian College of Physicians, Australasian Faculty of Rehabilitation Medicine and the Australasian Faculty of Pain Medicine. His research has included Electrophysiological Studies in Familial Amyotrophic Lateral Sclerosis with his primary paper, "Detection of pre-clinical motor neuron loss in SOD1 mutation carriers using motor unit number estimation" being widely cited in the international literature. He was awarded the Australian Association of Neurologists Young Investigator Award for his presentation of this paper in 1999 and was nominated for the Delsys Prize in 2012. He has written 3 book chapters on this subject and has also published widely on a number of different topics. He currently has a number of research projects in the areas of Chronic Pain and Parkinson's Disease. He is on the Editorial board of the Journal of Clinical Trials. He is the current Chairman of Australian & NZ Association of Neurologists Neuro-Rehabilitation Sub-Committee and on the Medical Advisory Board of Trigeminal Neuralgia Association (Australia).

Dr. Rucha Majmundar Mehta is practicing as an independent GCP Auditor (Free Lancer) based in India and conducting Audits for Multi National pharmaceutical Companies across Asia Pacific and European Region including UK. She has developed a Clinical Research Site in a privately owned small sized hospital and heading the site till date. She was providing QA consultation and training to various study sites and QA department of Pharmaceutical Companies. She conducts GCP Sessions during Investigators Meetings globally.