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ACDM19 Speaker Details

Marcus Schwabedissen

Marcus Schwabedissen

Q-FINITY

Biography:

Marcus has been in the life science industry for more than 20 years, and spent most of that time in Computerised System Validation, Risk Management, Quality Management and Quality Assurance. Over the last 14 years he was in charge of different leadership positions, which included Head of Global Technology Quality Management and Head of the QA Computer Technology Auditing Group at PAREXEL. Marcus has a proven history of getting to the heart of matters impacting Quality or Information Security, with clear insight into gaps, threats and remediation solutions. Adept at leading worldwide programs and projects to deploy frameworks, systems, and controls that transform how companies handle risk prevention and mitigation. Recognized for driving continuous improvement at all levels, with a key focus on transformation in project management and systems controls including computerized system validation. In 2017, he joined Q-FINITY, a consulting company for risk-based Quality Management, Quality Assurance, GxP-Compliance and Continuous Improvement of Processes, Data and Computerized System Validation. As Chief Operating Officer he now takes care of the operational belongings of Q-FINITY.


Title of Session: AI meets GDPR

Description of Session:

New technologies, like mobile apps and wearables, present new opportunities for collecting data during clinical trials, while the growth of electronic health records and online communities creates new fields for recruiting qualified participants for clinical trials as well as using new research designs that embed clinical research into traditional medical care. Organizations are in the process of adapting to the new environment and learning how they can best operate within it. Artificial Intelligence (AI) is potentially one of the key drivers of progress, by supporting human activity in managing growing amounts of data, creating information and making quick decisions. The Data Mining and Business Intelligence abilities will reach new levels. In parallel, the legal landscape is also changing, e.g. in Europe. As of May 2018, with the application of the General Data Protection Regulation (GDPR), there is one set of data protection rules for all companies operating in the EU, wherever they are based. The goal is that people have more control over their personal data while businesses benefit from a level playing field. However, what impact does the GDPR in its current form have on the potential use of AI?

Learning Objectives:

Changes in the current business landscape.

Oportunities of artificial intelligence.

Impact of the GDPR with regards to the use of AI in Europe

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