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.(3) 12/1/2018 08:30 AM SANTA CLARA 580 Narinder Singh 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.(2) 7/21/2018 08:00 AM SANTA CLARA 825 Larry S Wigman View Enroll

Electronic Data Capture for Clinical Trials


A major trend among life science organizations has been the recent shift from manual, paper-based clinical data collection processes to the predominant use of electronic systems that expedite the availability of accurate clinical trial data. This course examines some of the key issues surrounding the industry's adoption of Electronic Data Capture (EDC) and gives students the opportunity to use EDC software on classroom computers during simulated clinical trials.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X410.(2) 6/22/2018 06:00 PM SANTA CLARA 580 Jeffrey H. E. Sonas 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


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.(3) 11/2/2018 06:00 PM SANTA CLARA 750 David A West 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


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

Medical / Clinical Terminology


A basic understanding of medical and clinical terminology is essential in clinical trials design and management. This interactive workshop, for individuals with no background in medical/clinical terminology or for those who would like a refresher, reviews common terms associated with medical research and development and clinical trials. Participants review both the meaning of each term and how it is applied within a practical context.
This workshop is a prerequisite for the Clinical Trials Design and Management Certificate program.




(2928)

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X800.(3) 9/15/2018 09:00 AM SANTA CLARA 325 Maria Filippou-Frye View Enroll

Clinical Data Management


High-quality clinical data are at the heart of a successful clinical trial. If the data are not complete or do not reflect the actual reported results, the analysis and the conclusions drawn from that analysis may not be reliable. This course provides clinical trial personnel a solid understanding of the steps involved in clinical data management from study site data collection through data extraction for analysis.

Prerequisites:


No prerequisites


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.(2) 7/9/2018 06:00 PM SANTA CLARA 750 Donald (Don) Y Young View Enroll

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