QFINITY · Events · Meet QFINITY
Where you meet us in person.
An overview of the events QFINITY has taken part in or will be attending - conferences, talks and webinars. You'll often find us at ISPE and ACDM events. Stop by and talk to us in person.
Upcoming events
ISPE Webinar with QFINITY | June 5, 2025
Webinar Topics:
Importance of Clinical Data: Understanding the critical role of data from clinical sites in the success of clinical trials and the risks associated with inadequate system validation or oversight.
Regulatory Expectations: An overview of EMA guidelines on computerized systems and electronic data in clinical trials, with an emphasis on compliance, data integrity, and system validation.
Challenges for Sponsors: A discussion of the difficulties sponsors face in establishing robust oversight of systems used at clinical sites, particularly in decentralized and hybrid trial models, to ensure regulatory compliance and data integrity.
This webinar is based on the “GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice (2nd Edition).” It offers practical insights and best practices for system validation and effective collaboration between sponsors and clinical sites.
About the Speaker:
Frank Henrichmann brings extensive expertise in quality management and computerized systems and will share valuable insights from his work at QFINITY.
Registration:
You can register for the ISPE webinar 2025 here.
Europe Annual Conference with QFINITY | May 12-14, 2025
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.
QFINITY’s CEO at the Lounges | March 25, 2025
QFINITY will be at the Lounges 2025. The event takes place from 25 to 27 March in Karlsruhe and offers the opportunity to learn about exciting topics, innovative solutions, and the latest developments.
QFINITY’s CEO Oliver Herrmann will be there to represent ISPE and give an update on the GAMP Community of Practice. His presentation will answer the following questions:
How can QA be strategically aligned?
How can the flood of documents be reduced?
How can validation be made more agile/scalable?
How can system quality be ensured?
We look forward to meeting you on-site.
You can find further information on the Lounges 2025 here.