On June 23–24, 2025, Marcus Schwabedissen, COO of Q-FINITY, will participate in the 4th ACDM AI Symposium in Frankfurt. This event brings together international experts in the field of clinical data science to discuss current developments, practical applications, and the regulatory and ethical challenges of using artificial intelligence (AI) in clinical research.

As a long-standing active member of the ACDM and a member of the Steering Committee, Marcus Schwabedissen plays a key role in shaping the strategic direction of the symposium. With his extensive experience in optimizing clinical data management processes and implementing innovative technologies, he provides valuable input for a quality-driven and future-oriented use of AI in data-driven healthcare.

His participation highlights Q-FINITY’s ongoing commitment to innovation, quality, and practical advancement in clinical research.

More information about the 4th ACDM AI Symposium can be found here.

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.

QFINITY will participate in the 45th GAMP D-A-CH Forum in Dortmund this year.

Venue: adesso SE, Freie-Vogel-Straße 383, 44269 Dortmund, Germany
Sponsor: adesso SE

Innovative strategies and current topics relating to CSV will once again be the focus of the 45th GAMP D-A-CH Forum. You can look forward to top-class presentations and exciting discussions on the latest developments in the industry.

This time with the following topics and presentations:

Module Type Package (MTP) for Pharma – Efficient modularization for more flexibility
AI-supported digital validation – How artificial intelligence is revolutionizing compliance
Exclusive surprise presentation – Let yourself be inspired!
QFINITY will also be on site again. Our experts are looking forward to discussing the latest trends and challenges with you. Take the opportunity to exchange ideas and expand your network.

Professional exchange in the Special Interest Groups (SIGs) at the 45th GAMP D-A-CH Forum

In addition to the presentations, the forum offers the opportunity to discuss current challenges and best practices in Special Interest Groups (SIGs). These groups promote the transfer of knowledge and provide valuable insights into forward-looking topics.

Current SIGs:

• AI & Artificial Intelligence
• Cybersecurity & resilience in GxP environments
• MTP for Pharma – The future of modular production
• GAMP & medical devices – best practices for the highest quality

More information can be found here.

QFINITY’s CEO, Oliver Hermann, and Senior Executive Consultant, Frank Henrichmann, will be attending the ISPE Annual Meeting & Expo in October. The event will take place in Charlotte this year. Their participation goes beyond their role as members of the ISPE GAMP Global Steering Committee. They recognize this event as one of the most important conferences of the year for the pharmaceutical industry. We are also pleased to have Frank Henrichmann featured in ISPE’s marketing efforts for the event, as seen in this video.

More information about the ISPE Annual Meeting: https://ispe.org/conferences/2025-annual-meeting-expo

Here you can see the Video: https://youtu.be/QYkq5SdMziE?si=P-3AjgSVGlSVsAIf

We are pleased to announce the next GAMP webinar for South Asia, focusing on Good Clinical Practice (GCP) and expertly presented by Frank Henrichmann.

Frank Henrichmann is Senior Executive Consultant at Q-FINITY, co-leader of the second edition of the ISPE GAMP Good Practice Guide on Validation and Compliance of Computerized GCP Systems and Data and co-chair of the GAMP Global Steering Committee.

The webinar will take place on November 28th at 9am PKT and will last 60 minutes.

His presentation will cover the following points:

• GCP: What makes it different from other GxP areas?
• Overview and challenges of validating computerized systems in a GCP environment
• Introduction to ISPE GAMP GPG: Validation and compliance of computerized GCP systems and data – Good eClinical practice (2nd edition)
• Q&A Session

The South Asia webinar is free of charge, but you must register in advance at https://tinyurl.com/GAMPGCP.

We look forward to welcoming you to this webinar.