„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?”
Oliver Herrmann, Q-FINITY Chief Executive Officer (CEO), Chairman ISPE GAMP D-A-CH, Member of the ISPE GAMP EU Steering Committee, Co-Chair of the GAMP R&D and Clinical Systems SIG, Member of the RQA DIGIT Committe.
Oliver Herrmann has been significantly involved in the planning, development, execution and auditing of strategies, projects, activities, and procedures for GxP regulated environments for over 15 years. His experiences have made him a much sought-after presenter for industry events all over Europe and the United States. Today Oliver is the CEO of Q-FINITY, which he founded in 2004 with the vision to combine process management with the requirements for the Validation of computerized Systems and to offer this package as an integrated service portfolio. Q-FINITY offers services to companies that have to comply with regulations in Asia, Europe and/or the United States. In 2009, he started an ISPE GAMP Special Interest Group (SIG), which shows and promotes the acceptance, awareness and application of current good automated manufacturing practice (GAMP) in the GCP area. In December 2018 the ISPE released their work as official GAMP Good Practice Guide “Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice”.
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. Between 2003 and 2017 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.