ISPE Europe Annual Conference London

QFINITY’s CEO Oliver Herrmann and Senior Executive Frank Henrichmann will be at the ISPE Europe Annual Conference, held May 12th-14th 2025 in London.

Oliver Herrmann will present:

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 bring subject matter expertise and experience in the regulated field. The recently published EMA guideline on computerized systems and electronic data in clinical trials sets out a detailed perspective on regulatory requirements and expectations for the clinical area. As regulated companies define their own quality management systems to meet CSV and DI requirements, the current guideline could push them in a direction that leaves less room for interpretation and flexibility. The concept paper for the update of the EU GMP Annex 11 is another indicator of where EU regulators are heading – and it implies a significant change. This presentation will give an overview of current GCP expectations, show how to address the upcoming challenges in the digital transformation of clinical processes, and compare these requirements with current GxPs. Finally, it will offer an outlook on what the future may hold for the regulation of computerized systems and data integrity.

Frank Henrichmann will present:

“Workshop “Digital Transformation and GAMP: Implementing an AI Solution in a Pharma 4.0 Context”

Integrating innovative AI solutions is a cornerstone of the transition toward data-driven organizations and digital transformation. At the same time, ensuring patient safety and achieving and maintaining regulatory compliance remain priorities within GxP-regulated areas. Pharma 4.0 principles and GAMP concepts help achieve these goals, with specific maturity assessments and risk management techniques 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.

You can find more information about the Europe Annual Conference here.