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


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


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

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

Medical Writing


All biopharmaceutical companies must produce scientific reports and summary documents for regulatory agencies. Good documentation should be not only scientifically sound, but also clear, effective and concise. This course provides the practical skills needed to write effective documents for the healthcare industry. You'll gain practice through hands-on exercises and group projects based on documentation used in pharmaceutical development.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X413.(2) 6/15/2018 06:00 PM SANTA CLARA 750 David A West View Enroll

Clinical Project Management


This course addresses critical elements in the effective planning and management of clinical trials. Exercises and case studies illustrate how to develop and manage activities, timelines and budgets; examine staffing and resource requirements; and lead and motivate effective teams. Strategic development plans, team and site performance problems, and post-marketing studies are also discussed.

Prerequisites:


Offering code Offering title
REGL.X400 Good Manufacturing Practices
BTEC.X401 Drug Development Process
CTDM.X411 Good Clinical Practices

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