Clinical Trials Site Monitoring I


This course presents the essential elements of monitoring a clinical trial and the interaction between a sponsor and one or more sites during a clinical investigation. The course covers expectations of the FDA, the sponsor, and the site. The process of site selection, budgeting, initiation visits, source documentation, regulatory documentation, and adverse event reporting are additional topics covered.

Prerequisites:


Offering code Offering title
CTDM.X411 Good Clinical Practices

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X404.(2) 4/21/2018 09:00 AM SANTA CLARA 750 Savita O. Sinha View Enroll

Good Manufacturing Practices


Familiarity with the Good Manufacturing Practices (GMP) regulations is necessary for employees engaged in the manufacture, regulation, quality assurance, and control of drugs and biologics. Through lectures, discussions, and case studies, you’ll gain an understanding of the FDA GMP and Good Laboratory Practice (GLP) regulations.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
REGL.X400.(1) 1/27/2018 08:00 AM SANTA CLARA 825 Narinder Singh View Enroll

Clinical Statistics for Non-Statisticians


Clinical studies succeed or fail on the strength of their statistics. This course takes a practical approach to address the fundamental statistical concepts essential for non-statisticians involved in clinical research. Through lectures, discussions and in-class exercises, the instructor explores clinical study designs, hypothesis testing, sample size calculations, assumptions, controls, endpoints, data-management principles, data presentations and analysis plans, methods of analysis, and conclusions.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X403.(1) 1/22/2018 06:00 PM SANTA CLARA 750 Gerald Peter Shabe View Enroll

Good Clinical Practices


Clinical research is governed by a set of broad regulatory requirements, industry standards and recommendations. Interpreting and implementing these “best practice” standards presents a challenge for all the stakeholders involved in human research. This course explores the framework and principles of Good Clinical Practice (GCP) as it relates to the roles and responsibilities of various stakeholders like the FDA, Investigator, Sponsor, IRB and the study subject.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X411.(2) 4/18/2018 06:00 PM SANTA CLARA 800 Narinder Singh View Enroll

Medical Devices: Regulatory Strategies and Marketing Pathways


Medical devices are different from drugs and biologics in their regulation and paths to market. Effective clinical trials design and management for devices requires a solid understanding of these issues. This course defines medical devices and explains routes to market, regulatory pathways, successful investigational device exemption (IDE) and PMA submissions to the FDA.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X412.(1) 1/16/2018 06:00 PM SANTA CLARA 675 Clarisa A Tate View Enroll

Preparing for FDA Inspections and Conducting Sponsor Audits


In the regulated pharmaceutical and biotech medical device industries, inspections by government agencies are often a prerequisite for new product-marketing approvals. Knowing what to expect and how to prepare for and respond to such inspections is as critical as conducting sound clinical research. As the FDA and other regulatory authorities increase the frequency of inspections, it is imperative that everyone involved in the development of new therapies be familiar with government inspection processes and their role during these inspections.

Prerequisites:


Offering code Offering title
CTDM.X411 Good Clinical Practices

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X414.(1) 4/6/2018 05:30 PM SANTA CLARA 580 Frances Ann McKenney View Enroll

Science of Clinical Trials Design


This course reviews the science that forms the basis of effective clinical trial design. You’ll learn to classify and describe trial design by stage in drug and device development. The course covers the purposes of clinical trials, including types of trial designs. You'll learn to define hypothesis and study objectives and determine population and sample size.

Prerequisites:


Offering code Offering title
BTEC.X401 Drug Development Process
CTDM.X411 Good Clinical Practices

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X415.(1) 1/17/2018 05:45 PM SANTA CLARA 765 Michael D Huston View Enroll

Data Privacy and Security for Healthcare and Biosciences


Many companies in the healthcare and bioscience industries utilize Protected Health Information (PHI) or Personally Identifiable Information (PII) to develop and test products such as medical devices and mobile applications, or to perform other services, including data analysis, on their customer’s healthcare related data. This course examines the important data privacy and security issues that govern these industries.

Prerequisites:


No prerequisites


Drug Safety and Adverse Events Reporting


Regulators, the public, and the medical community are scrutinizing the safety profiles of pharmaceuticals more closely than ever. Thus acquiring, verifying and reporting quality safety data are crucial to obtaining and maintaining product approval. This course introduces fundamental concepts essential to drug safety and adverse event reporting and how to apply them to situations encountered during clinical trials and post-marketing reporting.

Prerequisites:


Offering code Offering title
CTDM.X411 Good Clinical Practices
CTDM.X800 Medical / Clinical Terminology

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X409.(2) 6/2/2018 08:30 AM SANTA CLARA 580 Narinder Singh View Enroll

Clinical Trials Essentials: An Intensive One-Week Course


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.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X801.(1) 3/12/2018 08:30 AM SANTA CLARA 1865 Gerald Peter Shabe View Enroll

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