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; as well as 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.

A team of clinical research experts, including many instructors from the UCSC Extension Clinical Trials Design and Management Certificate Program, address the following:

Topics include:

• Drug and Medical Device Development Processes
• Clinical Trial Design
• Applied Statistics in Clinical Trials for the Non-Statistician
• Regulation of Clinical Research
• Roles and Responsibilities of Key Clinical Research Players
• Monitoring Clinical Trials
• Clinical Data Management
• Clinical QA, Auditing and Compliance
• GMP and the Transition to Full Scale Manufacturing
• Business of Clinical Research
• Globalization of Clinical Research

Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.

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