Pre-Summit Workshop:
Putting AI Into Motion Across GxP Organizations

Tues., August 20, 2019

Whether you are already using the power of AI in your organization, or just getting started, this workshop will support your ability to advance the impact of your results. Spend the day during this hands-on workshop diving into the challenges, opportunities and successful practices of artificial intelligence. Gain a deeper understanding of how to increase the success of the outcomes, decrease the risk of decisions you make from the algorithms, and increase the confidence you have in relying on the results. Register today for this interactive workshop, Tuesday, August 20, 2019, 8:30am-4:00pm at Xavier University.

Expert leaders will engage you in an immersive learning experience on the following aspects of Artificial Intelligence:

  1. Demystifying AI: Explore the differences between AI, machine learning, deep learning, cognitive learning, neural networks, natural language processing, natural language generation, and…the list goes on. A theoretical framework will be explored within a set of real world exercises, highlighting the GxP connotations. Don’t miss this opportunity to unravel the mystery so you can lead innovation across your organization.

  2. From Train to Trust: As we branch into innovative spaces, we need to bridge new approaches with existing expectations. Learn how to train algorithms in a way that gains trust through explainability and the credibility of the inputs provided. Understand the various levels of training, how they are performed, and what they mean.

  3. AI Risk Management: During this session, you will explore risk management related to product, data and patient risk. The holistic approach will prepare you for on-market success as you dive into the CMS ruling on interoperability as part of the 21st Century Cures Act, HIPPA/GDPR, data capture, data retention, data integrity and cybersecurity. The expert facilitators will also share an overview of possible risk approaches to products that include artificial intelligence. Importantly, this overview will pull together existing risk methodologies for you to build upon, instead of throwing out the foundation of everything you’ve known.

  4. Regulatory Expectations and Pathways for AI: Understand how traditional expectations of “validation” are impacted by systems that continuously learn, and how this could affect the success of your product approval if not supported with sound methodologies. During this session, you will learn how best to prepare your product filings with data and studies when AI is involved in your product and/or processes.

  5. AI Adoption Across Your Organization: Successful practices will be shared on how to gain adoption for the use of AI within your organization, the cultural changes needed, training on how to make decisions responsibly from the output, how to demonstrate to your organization the value of AI, while also providing realistic cost analysis and return on investment.

Participants will have an opportunity to dive into the Xavier AI Working Team publications to support their learning and next steps.

Expert Facilitators

Who Should Attend?

  • Quality, Regulatory, Operations, R&D, Clinical Trials and Supply Chain functions

  • Bring your data scientists and cross-functional peers! You will be able to better influence the advancement of your organization if your data scientist and cross-functional peers understand the vision, and together you understand the technical realities. No problem if you do not have a data scientist in your organization.

  • Regulators

  • Any life science industry

  • Companies of all sizes

  • Consultants and service providers to the life science industries


The Xavier AI Summit’s pre-summit workshop, Putting AI Into Action Across GxP Organizations, Tuesday, April 20, 2019, from 8:30am-4:00pm at Xavier University, is $850. For complete information on planning your trip to the workshop, click here. And continue your learning with FDA, industry experts, and your colleagues by attending the AI Summit sessions, August 21-22, 2019.