Clinical Trials: Medical Device and Drug Development

Increase your understanding of the essential U.S. medical device regulations, including device classification, organizing pre-market notification 510(k), and planning and submitting a Pre-market approval (PMA). Enhance your knowledge of topics that include: global vigilance requirements and labeling requirements, European Medical Device Directive 93/42/EEC (MDD), E.U. conformity assessments, meeting E.U. essential requirements, and developing a technical file for the E.U. Get a review of device registrations in Canada, Australia, Japan and Latin America.

This course presents a detailed overview of the regulatory requirements for the development and manufacture of pharmaceutical products. Individuals involved in manufacturing, quality control, research and development, and clinical studies will learn the latest information. Explore topics that include the product development process through commercialization; product characterization and pre-clinical evaluation; pharmaceutical industry requirements; clinical trial requirements, good manufacturing practices (GMPs); good laboratory practices (GLPs); FDA inspections, labeling, and advertising of medical products; and preparing Food and Drug Administration (FDA) submissions.

Clinical trials are designed to answer questions concerning the safety and effectiveness of medical products. Get an overview of clinical trials regulated by the FDA. Learn about the planning process underlying the Strategic Clinical Plan and regulatory submissions to the FDA. Explore topics including protocol development and implementation, i.e. study site selection, financial controls, timelines, and management of the site's operations; proper informed consent; Good Clinical Practices compliance; HIPAA; FDA regulations and guidelines; and post-market support studies.

The use of human subjects in clinical trials for drug and device development requires sound ethical practices. Explore topics that include FDA regulations and guidance, informed consent process, the make-up and function of Institutional Review Boards (IRB), the IRB review process, and basic biomedical ethics. Course topics are enhanced by guest case studies, small group discussions, and research document reviews.

Gain an understanding of the accepted good principles and practices applicable to the development and implementation of drugs and medical devices in a research environment. Enhance your knowledge of topics including: definition of GCPs; the affect of GCPs on the conduct of a clinical trial; applicable regulations from ICH, HHS, FDA, and the state; obligations of investigators, sponsors, monitors, SMOs, CROs, and IRBs in a research environment; and compliance and accountability during a clinical trial. Learn about the basic elements of the clinical data management process.

Whether designing investigational drugs and medical devices or conducting clinical trials, it is important to have a basic understanding of the form and function of the human body. Learn about human anatomy and physiology as related to pharmaceuticals and medical device design for clinical studies. Clinical examples and modeling techniques are used to demonstrate the applications of anatomy and physiology in the development of investigational drugs and medical devices. Course focus is on human safety in clinical studies.

Gain the knowledge to understand and comply with FDA Good Laboratory Practice (GLP) regulations for the conduct of animal/in vitro safety studies. Enhance your understanding of topics including: regulations from the Code of Federal Regulations (CFRs), European and Japanese regulations, typical methods of compliance, how GLP fits into the drug/device/biologic development process, and ethics regarding animal care. Learn about sponsor obligations and how to evaluate a contract laboratory. Visit a clinical research center to reinforce the importance of GLP guidelines and compliance.

Increase your statistical literacy and gain an understanding of the role of statistics in clinical trials. Enhance your knowledge of the statistical concepts, terminology, and methods essential to clinical trials including: Statistical aspects of trial design (specification of endpoints, identification of primary hypotheses, the role of randomization, sample size determination, controlling confounds); Statistical analysis of trial data (insuring data quality, selecting statistical methods that support design objective(s), interpreting results reported by statistical software); and Critiquing the statistical aspects of a trial report.

Learn about the handling, processing, storage, retrieval, and electronic submissions of clinical data. Gain an understanding of the issues and implications surrounding database setup and the data management process. Enhance your knowledge of applicable FDA regulations (Part 11), and guidelines and the documentation necessary to achieve FDA compliance. The course will be of interest to clinical data management professionals, clinical research coordinators, clinical research associates, project managers, and programmers who support the design and development of clinical databases.

Gain a working knowledge of the clinical trial researcher's role through an internship position. Interns must attend three meetings with the internship coordinator, work in a UC Irvine clinical research setting for 60 hours, and submit a report of their internship experience based on a daily log kept throughout the quarter. All candidates must attend the Information Meeting on September 26 to obtain the application packet and eligibility requirements. RSVP for the Information Meeting is required at (949) 824-6538 by TBD.

Increase your expertise on the application of new technologies and redesigned processes to streamline clinical trials. Learn how to improve the efficiency of traditional clinical research cycle-paper-based processes utilizing information technology. Participants gain valuable knowledge of electronic processes used to plan, collect (acquire), access, exchange and achieve data required for conduct, management, analysis and reporting of clinical trials. Increased information accessibility and flow will allow the faster conduct of clinical trials with higher built-in quality. Ultimately, this will lead to higher degrees of safety and well being of patients.

Structuring the knowledge and expertise to conduct a clinical trial is instrumental in establishing your project plan. Learn how to organize your clinical trials project teams, define specific responsibilities for each team member, and create a project plan for either U.S. trails or Global trials. Participants will evaluate clinical and regulatory strategies for U.S. and Global approvals and become familiar with common standards of operation (SOPs) for clinical trials. Also addressed is the financial management of a clinical trial, negotiating contracts, and understanding how to interact with contract research organizations (CRO's).