“Regulators have started addressing the expectations for these solutions, but there is still much to do, since regulated companies need detailed guidance on documentation required to ensure explainability and performance of each tool," emphasized Danilo Neri, Partner & Vice President Executive of PQE Group. "Just a few weeks ago, the final approval of the AI Act in the European Union was granted, representing the world's most advanced regulation on artificial intelligence, requiring documentation to address explainability. It is an important step, but it is equally important that penalties are effectively applied to offenders to not compromise consumer, worker, and citizen protection at the expense of innovation and market competitiveness. The full establishment of this division will allow us to consolidate our position as a leader in the sector, offering exceptional compliance approaches and tailor-made solutions to our clients that meet regulatory expectations and the increasingly complex market needs." PQE Group’s dedicated validation approach has been designed to meet the current regulatory expectations for machine learning-based tools and for Generative AI solutions.
PQE Group's partnership with the Canadian company GenAIz will further boost service capacity. GenAIz, focused on the use of AI for supporting humanity, has developed a platform to speed up decision-making and execution with better business insights. This collaboration will enhance PQE Group's ability to offer innovative solutions and the necessary validation packages required by GxP regulations and by incoming industry wide rules (e.g., European AI act). Led by Catherine Lunardi, CEO of GenAIz and a spokesperson at the G7 on AI and wellbeing, GenAIz's AI platform will leverage PQE Group's global presence, which includes more than 45 offices worldwide.
The Regulated Artificial Intelligence & Data Analytics division will be presented in a panel discussion and networking event in Rockville, MD, on July 17, 2024. Experts will discuss AI regulations and the future of life sciences, marking a significant innovation for the pharmaceutical and medical device industry.
The press and readers are warmly invited to the event.
Please confirm attendance and find more information by registering here: https://hubs.ly/Q02CMQrj0
