RAPS Webcast: How to Integrate the European Artificial Intelligence Act and Digital Health Regulations in Agreements (On Demand)
The European Artificial Intelligence (AI) Act is one of the most challenging new regulations facing manufacturers. The act introduces new concepts, like human oversight and data management, that regulatory professionals need to know about. Many agreements need to be setup before starting an AI project. This presentation will give you the knowledge you need to navigate this complex area, with an easy-to-understand, colorful overview.Registration Fees & Deadlines
Learning Objectives
- Understand key concepts of the EU Artificial Intelligence Act
- Understand how important regulations like medical device, privacy, health data, and intellectual property regulations interact
- Understand how to set up agreements for regulatory, development, and service requirements
Who Should Attend?
Regulatory Affairs Professionals and Product Developers.
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Speakers
Leo Hovestadt
Director Governmental Affairs, Elekta
Leo Hovestadt has over 35 years of international experience at Medtronic and Elekta in the medical device industry and was involved from the start with EU Medical Device Regulation (EU MDR) and the Artificial Intelligence Act.
Leo is director of governmental affairs at Elekta. He chairs and is member of regulatory and standardization workgroups in the medical device area. Leo is a regular speaker at congresses on a wide variety of topics including clinical evaluation, implantables and software.
