Rocky Mountain Area Colorado
SOCRA Rocky Mountain Area Chapter
- 1 hr CEU offered SOCRA Members
- Non SOCRA Members Welcome!
- Unfortunately we will not be offering teleconference options I apologize for any inconvenience that may be caused at this time-Stacey Houser
If you have any questions, please feel free to contact us at rockymtnSOCRA@gmail.com
Date: June 12, 2019 (Wednesday)
Time: 6-7 pm, doors open at 5:30pm
Location: Lilly Marks Conference Room, CU Medicine (formerly UPI) Building, AMC
Title of Session: FDA Approach to Assessing New Drugs - Regulatory Perspective
- Understand the primary regulatory roles of the FDA in evaluating new drugs for market approval
- Describe the FDA standards to establish efficacy and safety of a new drug
- Understand the current FDA guideline to establish safety of diabetes drugs
About the speaker: William R. Hiatt, MD, is a Professor of Medicine who practices Vascular Medicine in the Division of Cardiology, University of Colorado School of Medicine. He is Chief Science Officer of CPC Clinical Research which is a university-affiliated, non-profit Academic Research Organization (ARO). CPC Clinical Research is a global, full service ARO focused on the academic design and execution of clinical trials in cardiovascular disease, thrombosis, hypertension, diabetes and regenerative medicine.
Dr. Hiatt's extensive involvement in leading international Steering Committees and global cardiovascular clinical trial initiatives provides an expertise on clinical trial development. He is a past Chair of the United States Food and Drug Administration (FDA) Cardiovascular and Renal Advisory Committee (2003-08), served several years on the Endocrinologic and Metabolic Drugs Advisory Committee and currently serves as a consultant to the FDA. His research at the CPC has pioneered new methods to control endpoint variability in clinical trials. Dr. Hiatt has over 230 peer-reviewed publications. His current trial focus is in developing new therapeutics for peripheral artery disease addressing both limb symptoms and cardiovascular risk.
Active in many national societies, Dr. Hiatt is a past-president of the Society for Vascular Medicine, is a fellow in the American Heart Association (AHA) and the American College of Physicians and a past chair of the AHA Peripheral Vascular Disease Council. He is also the co-editor of the TASC international guidelines for peripheral artery disease. Dr. Hiatt serves on the editorial board as an associate editor for the Journal of Vascular Medicine, the Cochrane Review Group and is guest editor for Circulation and section editor for the Journal of the American College of Cardiology.
The American Heart Association (AHA) has formally honored Dr. Hiatt twice for his work in greatly expanding the understanding of the causes and treatment of cardiovascular disease and peripheral artery disease. In 2014, he was recognized as a Distinguished Scientist, and most recently he received the Clinical Research Prize in 2018.
He has received two outstanding medical student teacher awards and has been elected several times Best Doctors in America (most recently in 2012). In 2008 he received the Robert W. Schrier Award of Excellence from the Department of Medicine, University of Colorado and he received the Julius H. Jacobson II, MD Physician Excellence Award from the Vascular Disease Foundation. Dr. Hiatt's lifetime achievements are commemorated through the William R. Hiatt Endowed Chair for Cardiovascular Research.
Research activities include studies evaluating the pathophysiology and epidemiology of peripheral artery disease, mechanisms of supervised exercise as an effective treatment modality for claudication, and numerous clinical trials to develop new therapies for claudication and critical leg ischemia
SOCRA CEU's available: 1 (for SOCRA members)
SOCRA members and non-members welcome!