Multi-regional Clinical Trials Why be concerned ? A Regulatory Perspective on Issues Robert T. O’Neill Ph.D. Director, Office of Biostatistics Office of.
“Good Clinical Practices” in Meeting Regulatory Responsibilities Terry VandenBosch, RN, PhD, CIP, CCRP Senior Research Compliance Associate Office of Human.
Ethical Issues in Translational Research Emma A. Meagher, MD [email protected].
General Principles for Meeting Regulatory Responsibilities Terry VandenBosch, RN, PhD, CIP, CCRP Senior Research Compliance Associate Office of Human Research.
Monitoring and Special Considerations for Multi-Center Trials September 10, 2010 Pav Aujla, MS, CCRP, RAC Primo N. Lara, Jr. MD A Translational Innovation.
Dealing with the FDA – The Pharma Experience Uwe P. Trinks, Ph.D TMA Annual Meeting, Williamsburg, VA.
FDLI February 11, 2008 Bradley Merrill Thompson Managing and Complying with Clinical Trial Quality Obligations for Sponsors.
Scientific Data for Evidence- Based Drug Regulation Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research Food and Drug Administration.
Regulatory Authority Governing Clinical Trials Anthony J. Minisi, MD Director, Cardiology Fellowship Program.
Human Capacity Development in Cote d’Ivoire: A Collaboration for Pre-Service Training in HIV, TB and Malaria between the Elizabeth Glaser Pediatric AIDS.
Smoky Hill Family Practice Residency April 5, 2010 Darrel McCool, FACMPE Business Planning.
UC DAVIS OFFICE OF RESEARCH Overview of Good Clinical Practices (GCP) Investigator and Study Team Responsibilities Miles McFann IRB Administration Training.