Well-planned and well-executed clinical trials are the cornerstones of effective drug and medical device development. Offered in an accelerated format and taught by leaders in the biopharmaceutical industry, this course provides a unique opportunity for professionals from all disciplines to learn about the many facets of clinical trials--the complex process that ensures the safety and effectiveness of medical products.
Participants leave the program with an appreciation of the drug and device development process; good clinical practice (GCP) and other regulations (ICH and FDA) that guide the conduct of trials and protect human volunteers. Also covered are clinical trial phases and design strategies; the importance of informed consent and the role of the IRB; investigator selection and responsibilities; study site management and trial monitoring; statistical data analysis; and regulatory responsibilities and the role of the FDA.
This course benefits anyone working in the biopharmaceutical and medical device industries and the biomedical community who is interfacing with or conducting clinical research, including new clinical research associates and study coordinators; medical directors, physicians, nurses, pharmacists, and other health professionals; biomedical scientists; statisticians and database administrators; and business professionals.
Expert instructional team from 2010 course:
R. MICHAEL CROMPTON, J.D., M.P.H. is a regulatory affairs professional with more than 20 years of experience in the medical device industry. He is currently the vice president of Regulatory and Clinical Affairs and Quality at Micrus Endovascular Corp.
AUDREY ERBES, Ph.D., a marketing and business development consultant, Principal of Erbes & Associates and www.audreysnetwork.com, has more than 30 years of experience in the global biopharmaceutical industry, including project team role as business interface with clinical development
JERRY GEORGETTE, RN, MSN, CCRC, is a study nurse coordinator at the VA Palo Alto HCS and is past president of the Northern California Chapter of the Association of Clinical Research Professionals (ACRP).
MICHAEL HUSTON, M.B.A., B.S., is president of Huston Associates, LLC, and has more than 20 years of experience in the life science industry, from basic research to strategic drug development.
JACQUIE MARDELL, B.A., has a broad background in planning, implementation and analyzing clinical trials, and has lead teams in the preparation and execution of clinical development plans in many therapeutic areas.
JEAN MASONEK, RN, B.S.N., B.A., is the senior manager of drug safety at a Bay Area Biopharmaceutical company.
FRANCES A. MCKENNEY, M.S., is director of GCP compliance at Affymax. Ms. McKenney has more than 20 years of experience in the pharmaceutical/biotechnology industry, working for both sponsor/manufacturers and a CRO.
TAMMY MORTON-TAYLOR, M.S., has 18 years of research experience, with more than 13 years devoted to coordinating, monitoring and managing clinical trials. Her most recent clinical research focus has been in the medical device industry, where she has worked with devices for cardiology, women's health and endocrinology.
SUSANNE PROKSCHA, B.S., has worked in clinical data management and data management systems for more than 20 years and is the author of Practical Guide to Clinical Data Management.
EDWARD ROZHON, Ph.D., is a global studies manager in the Pharmaceutical Development Organization at Genentech/Roche. Dr. Rozhon has 22 years of pharmaceutical experience in nonclinical and clinical areas of drug discovery and development.
G. PETER SHABE, M.S., is a biostatistician and president of Advance Research Associates, Inc., a contract research organization (CRO) providing data-management and biostatistical services to the medical-device, biotech and pharmaceutical industries.
Students will earn 3.5 CEUs; registered nurses will receive 35 hours re-licensure credit. All participants who successfully complete the program will receive a UCSC Extension Certificate of Completion. For more information, please contact UCSC Extension's Applied and Natural Sciences Department at (408) 861-3860, or
program@ucsc-extension.edu.
