Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
Saturday - Sunday, 10-11 May 2025
2025 ISPE International Emerging Leader Hackathon
Students and recent graduates will be tasked with analyzing a problem statement, acting as a consultant group to help the company solve an issue, to pitch it to a panel of expert judges at the culmination of the Hackathon. At the end of the two days, each team will present a group of judges and industry leaders. The judges will evaluate the presentations, provide feedback to the teams, and identify the best solution.
All session times are listed in Central European Time (CET). Find your personal viewing time on the World Clock.
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GAMP
Tue, 13 May
Wed, 14 May
1015 – 1045
Nearly three years since the publication of GAMP 5 Second Edition it is an appropriate time to explore how GAMP 5 Second Edition has assisted companies in achieving high quality and effective computerized systems, what many further opportunities are available, and also some of the challenges that remain.
1045 – 1115
GAMP
Brendan Walshe, Integrity Solutions
Christopher Reid, ProductLife Group
Taking an in-depth look at ISPE GAMP 5 Second Edition, A Risk Based Approach to Compliant GxP Computerized Systems [1], section 2.1.4. How critical thinking, when applied correctly, removes common mistakes. Establish some common sense principles of risk management when applying to different types of Computerized Systems, from ERP to GAMP category 3 systems. This presentation will address common mistakes that practitioners may currently be making around Functional Risk Assessments.
1115 – 1145
As the pharmaceutical industry advances towards greater automation and efficiency, the integration of digitalized project execution tools is essential for optimizing project outcomes. This presentation will explore the assessment and implementation of software tools in line with GAMP5 2nd Edition guidelines, focusing on supplier project execution systems and their potential benefits.
We will cover:
- The evaluation of supplier execution tools and their impact on time, cost, consistency, and quality.
- Innovations in automated design-to-code processes and smart commissioning, highlighting efficiency gains.
- Future enhancements through AI for code validation and automated testing.
- Lessons from suppliers using customer-owned platforms, like Kneat and QALM, and the challenges of technical and workflow alignment.
- Key strategies for integrating these tools into Project Validation Strategies, including supplier engagement, role clarity, and validation workshops.
We will cover:
- The evaluation of supplier execution tools and their impact on time, cost, consistency, and quality.
- Innovations in automated design-to-code processes and smart commissioning, highlighting efficiency gains.
- Future enhancements through AI for code validation and automated testing.
- Lessons from suppliers using customer-owned platforms, like Kneat and QALM, and the challenges of technical and workflow alignment.
- Key strategies for integrating these tools into Project Validation Strategies, including supplier engagement, role clarity, and validation workshops.
1315 – 1345
GAMP
Chris Kenny, JDI Digital Transform LTD
Paul Irving, Northern Life Sciences Ltd.
Applying GAMP 5 Second Edition Key Concepts to Enable a Successful Health Cloud Platform Implementation
A Case Study, detailing how we utilized GAMP 5 Second Edition to help a leading Life Sciences Organization Implement and Validate the following Health Cloud Platform, a description of functionality and capabilities are detailed below.
- Health Cloud (HC) is a modular platform built on Technology contextualized for the Health and Life Sciences sector.
- It allows the organization to connect Hospitals, Nurses, Patient Services, and Pharmacy with our Patients through a series of Cloud Services:
- Health Cloud CRM – Manages the Patient Record and is the central view of the patient's needs: Assets, Regimens, Stock Levels, Prescriptions etc.
- Communities – Enables connection via the HCP Portal (for patient referrals and ongoing communications) and Patients (for day-to-day contact within the organization) via the Patient Portal.
- Application Field Service – Enables Field Based care through efficient high-volume route planning and patient-facing treatment management.
- All the above sits within a Life Sciences Organization that can be expanded to other business units.
A Case Study, detailing how we utilized GAMP 5 Second Edition to help a leading Life Sciences Organization Implement and Validate the following Health Cloud Platform, a description of functionality and capabilities are detailed below.
- Health Cloud (HC) is a modular platform built on Technology contextualized for the Health and Life Sciences sector.
- It allows the organization to connect Hospitals, Nurses, Patient Services, and Pharmacy with our Patients through a series of Cloud Services:
- Health Cloud CRM – Manages the Patient Record and is the central view of the patient's needs: Assets, Regimens, Stock Levels, Prescriptions etc.
- Communities – Enables connection via the HCP Portal (for patient referrals and ongoing communications) and Patients (for day-to-day contact within the organization) via the Patient Portal.
- Application Field Service – Enables Field Based care through efficient high-volume route planning and patient-facing treatment management.
- All the above sits within a Life Sciences Organization that can be expanded to other business units.
1345 – 1415
GAMP
Carsten Jasper, Charles River Laboratories Inc
Most laboratories have to deal with legacy laboratory systems that do not fulfill current regulatory and data integrity expectations. These systems often use inefficient hybrid paper-based mitigations or pose high risks to the integrity of data. Additionally, those systems slow down digital transformation. Based on a use case this presentation will showcase a potential solution for such systems. This solution is LabMonitor from CIMCON Software. After a short introduction of the use case (a digital transformation project for a mid-size laboratory), the software and its main features will be explained, and based on the practical aspects the potential of such software will be showcased. Another focus will be on points to consider when such a solution is being used for digital transformation and improvement of data integrity.
1415 – 1445
GAMP
Thomas Makait, QPRI
Markus Fink, Siemens AG, DI PA PHA
In past years, the pharmaceutical industry increasingly perceived their manufacturing facilities as being too static and inflexible. Shorter time to market and faster changeover times raised the need for new concepts. Modularization and standardization in plant engineering, as well as automation and operations, paved the way and resulted in the concept of standardized Module Type Package (MTP). To compliantly and efficiently implement the new MTP concept in modular plants, the Global GAMP Special Interest Group for Qualification and Validation of Modular Plants was founded, and some of the working results will be presented. The objective is to present a holistic data-driven and integrated approach to the qualification and validation of such plants. This standardized approach will be the basis for delivering compliant modular plants as efficiently as possible, ideally starting already during the very early end of process development and early engineering phases. Inherent elements of a modular plant are Process Equipment Assemblies (PEAs), previously called package units or skids, and a superior Process Orchestration Layer, the so-called POL. These two levels communicate with each other via a standardized MTP interface.
1530 – 1600
GAMP
Costanza Stocchi, MAASI Enterprises
Irene Barlacchi, MAASI Enterprises
Eugenio Benedetti, Siena Imaging
Francesco Sforazzini, Siena Imaging
The integration of AI/ML foundation models into medical imaging offers significant opportunities for enhancing clinical decision-making. However, it also introduces important compliance challenges, such as adherence to medical device regulations, patient data privacy laws, and the need for transparent model interpretability. Regulatory bodies require that AI/ML models used in healthcare undergo rigorous validation to ensure their safety, efficacy, and applicability across diverse patient populations. Additionally, the use of foundation models raises concerns about algorithmic bias, which could affect diagnostic accuracy and exacerbate healthcare disparities. To explore these challenges, we propose a specialized deep-learning study model for detecting neurodegenerative changes in the human body. This solution is outlined from its initial design through the training phase, along with the proposed validation strategy to ensure robustness, accuracy, safety, and reliability of the results.
1600 – 1630
The objective of the presentation would be to explore the critical role human factors and associated controls (i.e., human-in-the-loop) play in the oversight of AI and machine learning system development. It would aim to highlight the importance of ethical considerations, transparency, and accountability in mitigating potential risks and compliance aspects. By addressing these factors, it will discuss strategies for ensuring that AI systems are designed, developed, and deployed responsibly and in a GxP-compliant manner.
1630 – 1700
GAMP
Martin Heitmann, D-fine GmbH
Mohammed Rahman, OPDC
Digital Quality & Validation for Personalized Medicine: AI, Sequencing, and Digital Biomarkers
As the life sciences industry evolves, the integration of AI, sequencing technologies, and digital biomarkers, coupled with strong digital quality and validation processes, is at the forefront of personalized medicine. This proposal explores how these next-generation technologies are transforming healthcare by offering patient-specific treatment plans based on a deeper understanding of disease mechanisms and drug responses, validated for accuracy and compliance.
Personalized medicine, supported by AI and digital biomarkers, requires rigorous validation to optimize drug development processes, ensuring efficacy and safety while maintaining regulatory adherence. Digital quality frameworks play a pivotal role in verifying the accuracy of AI algorithms and ensuring that digital biomarkers meet industry standards. This presentation will focus on two key aspects: the predictive capabilities of AI and the validation strategies that support their implementation in personalized medicines.
Attendees will learn how machine learning models predict adverse reactions, identify actionable biomarkers, and guide clinical decisions, with digital quality ensuring the integrity of these models. Additionally, insights into the validation of real-time data from wearable devices will be provided, showing how these processes contribute to patient-centric care.
As the life sciences industry evolves, the integration of AI, sequencing technologies, and digital biomarkers, coupled with strong digital quality and validation processes, is at the forefront of personalized medicine. This proposal explores how these next-generation technologies are transforming healthcare by offering patient-specific treatment plans based on a deeper understanding of disease mechanisms and drug responses, validated for accuracy and compliance.
Personalized medicine, supported by AI and digital biomarkers, requires rigorous validation to optimize drug development processes, ensuring efficacy and safety while maintaining regulatory adherence. Digital quality frameworks play a pivotal role in verifying the accuracy of AI algorithms and ensuring that digital biomarkers meet industry standards. This presentation will focus on two key aspects: the predictive capabilities of AI and the validation strategies that support their implementation in personalized medicines.
Attendees will learn how machine learning models predict adverse reactions, identify actionable biomarkers, and guide clinical decisions, with digital quality ensuring the integrity of these models. Additionally, insights into the validation of real-time data from wearable devices will be provided, showing how these processes contribute to patient-centric care.
1100 – 1130
GAMP
Brendan Walshe, Integrity Solutions
Mary White, Amneal Ireland Ltd
Presentation of Data Integrity / Data Mapping Risk assessment completed for Process Equipment. The risk assessment was completed using the APIC (Active Pharmaceutical Ingredients Committee) Practical risk-based guide for managing data integrity Version 1, March 2019. The presentation shall outline the steps taken with actual examples and the results for each step. The high level steps performed for each set of process equipment is as follows: 1. Process Mapping - Process Flow Mapping 2. Data Process Mapping - Identify data flows (In/Out) and GxP data elements (paper and electronic). 3. Data and System Categorization 4. System Assessment - Assess the gaps within the system using a Data Integrity (DI) check list. 5. Analyse the DI risk - Conduct a risk assessment(FMEA) on the gaps identified and impact on GxP data that can be modified/deleted or re-reprocesses after creation. 6. Risk Management Plan – actions and priorities to address risks identified.
1130 – 1200
This session provides practical guidance on ensuring compliance for digital systems at clinical sites, focusing on strategies aligned with EMA expectations and insights from the updated ISPE GAMP guide on eClinical systems. Attendees will learn essential aspects of regulatory requirements, effective implementation methods, and ongoing verification practices to maintain continuous compliance. The session highlights the benefits of digitalization, such as improved efficiency and data quality, while addressing common pitfalls and validation mistakes to avoid. It is designed to help decision-makers ensure compliance while enhancing the overall performance of clinical activities.
1200 – 1230
GAMP
Oliver Herrmann, Q-FINITY Quality Management
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, which implies a significant change. This presentation will provide an overview of current GCP expectations and how to address the upcoming challenges in the digital transformation of clinical processes and 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.
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, which implies a significant change. This presentation will provide an overview of current GCP expectations and how to address the upcoming challenges in the digital transformation of clinical processes and 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.
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.