Re-imaging the World´s Economic Data Remember the "Kodak Moment?' It was a term in photography popularized by Kodak to capture important moments. Well, right now there is a Kodak Moment going on in healthcare information sciences. It is associated with the attribute-based data structures that are the basis for the revolution in genetic diagnostics, clinical risk management, and personalized medicine. It is also the foundation and source of the advances in Big Data and Artificial Intelligence in healthcare. In this session, you will learn about a new innovation in business information management called the Locus Model and a new type of business information system called the Functional Information System (FIS). These important innovations have the potential to impact all data management in business, finance, and economics by introducing a universal standard that can unify the disparate systems in disparate countries that we currently use to classify and organize business, finance, products or job information. This and other IIL Learning in Minutes presentations qualify for PDUs. Some titles, such as Agile-related topics may qualify for other continuing education credits such as SEUs, or CEUs. Each professional development activity yields one PDU for one hour spent engaged in the activity. Some limitations apply and can be found in the Ways to Earn PDUs section that discusses PDU activities and associated policies.
Design Thinking for a Circular Economy Design Thinking for a Circular Economy The most critical and complex problem of our age is how to create a robust economy that is sustainable for all future generations. Design Thinking is a revolutionary and practical methodology, with principles and processes that help people approach complex problems and create collaborative, innovative, and human-centered solutions for Sustainability. The Circular Economy utilizes restorative and regenerative methodologies like 'cradle to cradle' and 'biomimicry' to reshape how we do business, while fostering robust equitable economies. In this dynamic presentation, we will explore how the Circular Economy depends on Design Thinking in order to re-think and re-make our systems and products with an understanding of our Value chains as Material flows. When we create an economy that is just for all, and that fits into our ecological system as opposed to ecology bending to our economy, then we can produce a future that is Sustainable for all. This and other IIL Learning in Minutes presentations qualify for PDUs. Some titles, such as Agile-related topics may qualify for other continuing education credits such as SEUs, or CEUs. Each professional development activity yields one PDU for one hour spent engaged in the activity. Some limitations apply and can be found in the Ways to Earn PDUs section that discusses PDU activities and associated policie
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Traibcert Online Foundation Courses, Elementary Training and Rudimentary Coaching are uniquely and specifically structured and designed to upgrade individual skills, improve intellectual minds to accumulate excessive knowledge and develop the respective standards essentially required to confidently encounter the competitive challenges that pragmatically exist within the peripheral margins of Multi-national corporates that encapsulate the giant organisations and empires of industry.
Traibcert Online Foundation Courses, Elementary Training and Rudimentary Coaching are uniquely and specifically structured and designed to upgrade individual skills, improve intellectual minds to accumulate excessive knowledge and develop the respective standards essentially required to confidently encounter the competitive challenges that pragmatically exist within the peripheral margins of Multi-national corporates that encapsulate the giant organizations and empires of industry.
The eCTD is mandatory for all applications for marketing approval and all subsequent related submissions in the European Economic Area, the USA and Canada. Other countries intend to make its use mandatory. The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of medicinal product dossiers for regulatory applications. It broadens the scope of the CTD to include information on variations, renewals and amendments, so that it is no longer a static document but is updatable throughout the life of the product. This module outlines the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission. The module provides a training and reference tool that will be of particular value to those new to the use of the format.
The module describes general principles of GCP inspection and audit, discusses preparation for an inspection, and sets out in detail what European and US FDA inspectors will examine. Finally it describes post-inspection actions by the regulator and the inspected party.
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