This 90-minute course will give you practical answers to frequently-asked best practice questions regarding the new responsibilities outlined in ICH 6 for sponsors, investigators/sites and monitors.
This course presents a succinct review of the differences between the draft and the final guidance, an example of an industry impact analysis, and finally a gap analysis tool to help guide decision-making and implementation planning.
View our 23-minute GCP refresher course! You’ll learn about recent updates to GCP in this short course from the LSTI webinar series. Select the "Purchase Course" button to download this course for free. Immediately after submitting your order, you'll receive a link to download access instructions for the webinar. The Life Science Training Institute’s GxP [...]
This session will give you the tools to set-up your hypotheses, identify the correct test to use, complete the test, and make your decision on the hypothesis in question. Additionally, the course will aid you in turning your statistical data into an answer that will make sense in the “real world.”
This session will give you the tools to interpret data, detect errors, and help you organize your data in an easy to understand format. This course will give you a foundation in biostatistics by detailing numerical summaries like mean, median, mode, variance, standard deviation, range, interquartile range (IQR), and coefficient of variation (CV).
Good Clinical Practice (GCP) inspections – announced or otherwise – are a fact of life and will affect your clinical research activities. Recognizing both US Food & Drug Administration (FDA) and European Medicines Agency (EMA) GCP inspection trends and procedures will keep your firm compliant. This course will show you how to prepare for, manage, and follow up with a health authority GCP inspection.
FDA finalized its guidance on submitting promotional materials using the Electronic Common Technical Document (eCTD). Beginning on June 24, 2021, all required submissions of promotional materials must be filed using the eCTD format. That means companies need to start acting now to ensure they’re prepared for this sea change in the way FDA receives promotional materials.
This session will be valuable to clinical trials and associated/related personnel looking for a foundational understanding of Trial Master Files (TMF), electronic Trial Master Files (eTMF), and inspection readiness.
This course will address the implementation logistics of the questions answered by the FDA in the guidance, to allow you to develop an implementation plan for the short and long term. Come to this session to learn how to take the FDA recommendations into specific industry settings including sites, sponsors and IRBs.
This webinar will look at the different components of a development plan and review the information needed to capture the essence of your project. Additionally, this course will enable you to have an appreciation and understanding of the processes and the various facets associated with planning for successful drug development.
The course will explore each interaction separately, taking a specific look at important strategies to help you shape and deliver your message. By attending this course, you will know what to say, what not to say, how to say it, and which communication vehicle will best suit your needs.
Whether you are kicking off a new project, trying to regain control of ongoing study financials, or just trying to gain best practices, this session will help reduce unpredictable scope increases and “wow” change orders, keeping you on top of your budget through your trial.
In this course, we will examine the “why” behind the mandate and how it can change the way therapies are being developed, leading to faster market delivery of better drugs. We will explore FDA’s vision of having electronic access to all submission data in ways that are not currently feasible. The electronic standards for exchange of nonclinical data (SEND) and clinical data (SDTM), developed by CDISC, will be discussed, focusing on SEND.
