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; 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 industry or 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.
Speakers for the 2008 course:
R. MICHAEL CROMPTON, J.D., M.P.H. is a regulatory affairs professional with over 20 years of experience in the medical device industry. He has held senior management positions at medical device start-ups as well as multi-national medical device corporations and practiced law at a leading food and drug law firm.
MICHAEL HUSTON, president of Huston Associates, LLC, has more than 20 years of experience in the life science industry, from basic research to strategic drug development. Mr. Huston has directed project teams through preclinical evaluations, Phase 1–3 clinical studies and numerous regulatory submissions.
JACQUIE MARDELL, B.A., has more than 20 years of pharmaceutical and biotech industry experience in both large and small companies. She has a broad background in planning, implementation and analysis of Phase 1-4 clinical trials and has lead teams in the preparation and execution of clinical development place in a wide range of therapeutic areas.
JEAN MASONEK, RN, B.S.N., has worked in drug safety for a large multinational pharmaceutical corporation and mid-sized and small biotech companies in the Bay Area. She is currently drug safety manager at a small pharmaceutical company on the peninsula.
FRANCES A. MCKENNEY, M.S., is the director of GCP compliance at Affymax. Ms. McKenney has 20 years experience in the pharmaceutical/biotechnology industry working for both sponsor/manufacturers and a CRO.
TAMMY MORTON-TAYLOR, M.S., is a clinical project manager for Bailer Research, a contract research organization specializing in cardiovascular medical devices. She has 16 years of research experience, with more than 10 years devoted to coordinating, monitoring and managing clinical trials.
NANETTE NANJO-JONES, M.B.A., formerly the director of contracts and proposals/business development for ICON Clinical Research, is now an independent outsourcing consultant. She has more than 12 years of experience in the biotechnology/pharmaceutical industry, from financial analysis to clinical-site budget negotiation and contracts management.
SUSANNE PROKSCHA 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 the senior manager of clinical trial management at Genentech and was formerly the associate director of development planning and program management at PPD Development. Dr. Rozhon has 18 years of pharmaceutical experience in preclinical and clinical areas of drug discovery and development.
PETER SHABE, M.S., is president of Advance Research Associates, Inc., a contract research organization (CRO) providing data-management and biostatistical services to medical-device, biotech and pharmaceutical industries.
Fee includes all course materials, continental breakfasts, daily snacks and a networking lunch on the first day.
Students will earn 3.5 CEUs; registered nurses and social workers will receive 35 hours relicensure 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.
