Europe Annual Conference with QFINITY | 12.-14. May 2025
QFINITY´s CEO Oliver Herrmann and Senior Executive Frank Henrichmann will be at the ISPE Europe Annual Conference. The Conference will take place from May 12th-14th 2025 in London.
Oliver Herrmann will give a presentation about:
Are the Current EU GCP CSV/DI Requirements a Blueprint for Other GxPs?
This presentation will show you why it’s so important to work with critical thinkers who have the subject matter expertise and experience in the regulated field. The recently published EMA guideline on computerized systems and electronic data in clinical trials defines a detailed perspective of regulatory requirements and expectations for the clinical area. As regulated companies define their own quality management system to meet CSV and Di requirements, the current guideline could lead to a direction that reduces the possibility of interpretation and flexibility. Another indicator of the current thinking of the EU regulators could be the concept paper for the update of the EU GMP Annex 11. That implies a significant change. This presentation will provide an overview of current GCP expectations. It will also show how to address the upcoming challenges in the digital transformation of clinical processes. Moreover it compare these requirements with current GxPs. Finally, the presentation will provide an outlook on what the future may hold for the regulation of computerized systems and data integrity.
Frank Henrichmann will present on the topic:
“Workshop “Digital Transformation and GAMP: Implementing an AI Solution in a Pharma 4.0 Context”
Integrating innovative AI solutions serves as a cornerstone in the transition toward data-driven organizations and digital transformation. At the same time, ensuring patient safety, maintaining, and achieving regulatory compliance remain priorities within GxP-regulated areas. Examples of Pharma 4.0 principles and GAMP® concepts help in achieving these goals, where specific maturity assessments and risk management techniques have been established for application in an AI context.
This interactive workshop led by Frank Henrichmann, Martin Heitmann, Brandi Stockton and Paige Kane delves into practical aspects of implementing AI in a GxP-regulated environment, guided by the principles and guidance established in ISPE Pharma 4.0® and GAMP®. Participants will explore maturity assessment techniques to evaluate organizational readiness for digital transformation, focusing on critical factors such as infrastructure, culture, and existing processes. They will also have the chance to explore a comprehensive risk assessment methodology tailored to AI solutions. The main focus will be on methods for identifying and mitigating risks to patient safety, data integrity, and product quality.
Through real-world examples and hands-on exercises, attendees will gain actionable insights into aligning AI implementation with digitization objectives while fulfilling quality expectations and adhering to regulatory requirements.
More information about the Europe Annual Conference can be found here.
