Full course description
The Georgia Clinical & Translational Science Alliance- Georgia CTSA andSC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.
An overview of how clinical trial simulation is used to evaluate optimal design selections, trial criteria and execution, and strategies to eliminate early errors will be examined.Case studies highlight the integration of real-world data becoming real-world evidence that leads to cost effective labeling change of medical drugs/devices.Distinctions between physiologically based pharmacokinetic and pharmacodynamic models will be explored.
- Part I: Definitions
- Real World Data (RWD)
- Real World Evidence (RWE)
- Applications for RWE based on RWD
- Part II: Case Studies: Drug Development Tools
- Why do drug development programs fail?
- Clinical trial simulations
- Clinical trial simulator for Alzheimer’s disease
- Comprehensive data integration
- Model endpoints/covariates
- Implications for application
- Extend validation
- A successful pathway for regulatory endorsement of quantitative drug development tools
- Exemplars: Case studies
- Part III: Case Studies: Medical Devices
- Medical devices
- Transcatheter aortic valve replacement
- Patient-level registry data
- Medical devices
- Part IV: Case Studies: Drugs
- Physiologically Based Pharmacokinetic Dynamic Modeling (PBPK)
Klaus Cepeda, MD, MS, FCP is a clinical pharmacologist and epidemiologist, with 15 years combined experience in academic and drug development clinical research. He is a fellow of the American College of Clinical Pharmacology and the American Society for Clinical Pharmacology and Therapeutics, as well as a founding member of the International Society of Pharmacometrics. He has conducted research on disease modeling for neurodegeneration, physiologically-based pharmacokinetic modeling for infectious diseases, endemic channels for non-steroidal anti-inflammatory drug-related gastropathy, antibiotic-related dysglycemia, drug-induced QT prolongation, pharmacoepidemiology, and patient education. Dr. Romero has been with C-Path since January of 2008, where he has led the quantitative medicine team, which spearheaded clinical pharmacology, pharmacoepidemiology and modeling, and simulation projects for the Critical Path for Alzheimer’s disease consortium, the Critical Path for Parkinson’s disease consortium, the Polycystic Kidney Disease Outcomes consortium, the Critical Path to TB drug regimens consortium, the Transplant Therapeutics Outcomes consortium and the Type 1 Diabetes consortium, achieving major milestones such as the first regulatory endorsement by FDA and EMA of a clinical trial simulation tool for mild and moderate Alzheimer’s Disease; the first EMA letter of support for a pre-dementia Alzheimer’s disease progression model; the first clinical biomarker qualification for polycystic kidney disease; and the first clinical biomarker qualification for Parkinson’s disease. Dr. Romero joined the USC School of Pharmacy as an Adjunct Professor of Clinical Pharmacy, with the vision of creating a Center for Quantitative Disease and Drug Modeling. He is fluid in English, Spanish, German and Portuguese, and has published in the areas of clinical pharmacology, pharmacometrics, quantitative medicine, cardiovascular drug safety, and pharmacoepidemiology. firstname.lastname@example.org
Learner Level: Intermediate/ Advanced
Intermediate to Advanced: This program is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals or junior faculty with 3+ years of experience seeking to further develop clinical research conduct skills and principles.Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor/ CRO challenges.
Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. Attendees to this CNE activity will be awarded 1.25 Continuing Nursing Education contact hours from ENPDC.
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Program Information: This is the fourth course in a five (5) session program. To complete the entire program and earn a badge CLICK HERE.