Programme
Featured Sessions
ISPE Foundation Professional Development Grant Orientation
ISPE & the ISPE Foundation invite students and recent graduates to join us for a session to get the most out of your experience at the 2024 ISPE Europe Annual Conference. You’ll gain career advice, learn about the benefits of your ISPE membership, and participate in an interactive discussion. This session is tailored specifically to recipients of the ISPE Foundation Professional Development Grant.
Monday, 15 April 1500 - 1600
ISPE International Hackathon
The ISPE Europe Emerging Leaders Community is inviting participants with less than 5 years of experience in the pharmaceutical industry to join us at the 2024 ISPE EU Hackathon. The Hackathon will be hosted from Saturday-Sunday, 13-14 April in Lisbon, Portugal preceding the 2024 ISPE Europe Annual Conference.
Saturday - Sunday, 13-14 April
All session times are listed in Western European Time (WET). Find your personal viewing time on the World Clock.
Live-streamed education sessions.
Before the Event
Mon, 15 Apr
-
1200 - 1700Registration Open
-
1300 - 1600Digital Transformation - Practical Implementation of New Technologies
Case studies: GxP Implementation of:
- PAT (Process Analytical Technology) in continuous manufacturing
- AR/VR (Augmented Reality/ Virtual Reality) and other technologies to Digitalise the learning journey
Organizations seeking to keep up with the digital transformation are investing in new technologies with an end-to-end (E2E) focus on their products and processes, aiming to improve operational excellence, worker experience, product quality and delivery timelines. Adoption of these new technologies requires a systematic, structural, and holistic transformation of individuals and the organization. Smart organizations of today and the future need to effectively capture, maintain and share their data, information and knowledge - including their people’s implicit and tacit knowledge - to maintain a competitive advantage and meet these high demands.
During this workshop, participants will explore multiple ISPE industry guidance (e.g. Pharma 4.0, PAT, GAMP, Knowledge Management, APQ guides) in an interactive discussion session and hear from industry experts with extensive experience in digital project/program implementation. Participants will engage in one of two case studies and learn how guidance can be applied for successful implementation of these new technologies, with a focus on people change management and best practices for sustaining the business process while navigating the digital transformation and technology adoption.
- Collective group discussion with an overview of industry guidance to set the stage for technology implementation.
- Participants will be divided into two groups to work on one of two case studies: PAT (Process Analytical Technology) application in continuous manufacturing or AR/VR Augmented Reality and Virtual Reality for upskilling and training
- Both groups will work on developing a case study specific plan based on industry guidance and experience of the workshop leaders and participants.
- Participants will identify good practices and pitfalls in project approval, implementation and sustainability.
- Each group will report back and share their experiences in the collective group discussion.
- The output of the workshop will be utilized and presented on the ISPE blog and/or the Pharmaceutical Engineering magazine.
Speakers
-
1300 - 1600GAMP Basics: Digital IntegritySpeakers
-
1300 - 1600Facility Tour - HikmaHikma Pharmaceuticals Portugal: Sterile Injectable Facility
For 45 years, Hikma Pharmaceuticals has been making high-quality medicines and making them accessible to the people who need them. Tour the state-of-the-art Hikma Pharmaceuticals Portugal Sterile Injectable Facility, which serves as a global hub for the Injectables business, the largest of Hikma’s three divisions.
Attendance is limited to 40.
Facility Tour registration closes 5 April.
Visitors must wear clean closed toe shoes and long pants, and will be gowned according to local procedure. Photography will not be allowed. -
1500 - 1600ISPE Foundation Professional Development Grant OrientationISPE & the ISPE Foundation invite students and recent graduates to join us for a session to get the most out of your experience at the 2024 ISPE Europe Annual Conference. You’ll gain career advice, learn about the benefits of your ISPE membership, and participate in an interactive discussion. This session is tailored specifically to recipients of the ISPE Foundation Professional Development Grant.
Day 1
Tue, 16 Apr
-
0800 - 1830Registration Open
-
0900 - 0920Welcome to the ISPE Europe Annual Conference
-
0920 - 0930Remarks from the Executive Chair
-
0930 - 1000Commercializing Autologous Cell TherapiesThe US FDA recently granted accelerated approval for Iovance Biotherapeutics’ AMTAGVI™ as the first and only one-time, individualized T cell therapy treatment for Metastatic Melanoma opening the doors for many future state advanced therapies in solid tumor treatment. This keynote presentation discusses the overall journey of how the world’s 1st solid tumor cell therapy went from bench scale research at Dr. Steven Rosenberg’s laboratories to being a FDA approved commercial therapy. With 2,000+ cell and gene therapies in clinical trials worldwide, regulators including US Food and Drug Administration, Health Canada and European-Medicines Association, will determine whether these innovative therapies move from the laboratory to the market. The session will provide the audience an exclusive look at the overall cell therapy market landscape, key learnings from unique CMC matters to scaling-up personalized therapies and to what regulators are expecting from late-stage oncology companies to receive expedited approvals. Lessons learned from both CAR-T and TIL launches will be discussed to shed light on what others can do to enhance their opportunities to accelerate both the development and approval of advanced therapies for the treatment of cancer and rare diseases.Speakers
-
1000 - 1030The Magic of MushroomsThe Magic of Mushrooms: How Learning from Fungi Ecosystems can Help Us Design the Function and Features of Our Future
Andrea “Andi” Goddard, Head of Global Pharmaceutical Technical Operations Quality & Compliance at Roche, explores one of the greatest challenges to the future of pharmaceutical manufacturing – designing, sustaining, evolving and navigating the increasingly complex industry and organizational networks necessary to deliver for patients. Andi hypothesizes that the natural world, which has been building, shaping, and evolving complex networks of its own for millions of years, may provide our industry with inspiration and insights. Examining the world of subterranean fungal networks, Andi looks at how they connect living organisms, facilitate the complex exchange of signals, information and resources and help sustain entire ecosystems - and considers what we can learn as we build and create the future of manufacturing.Speakers
-
1030 - 1040Welcome from the ISPE Vice President of European Operations
-
1040 - 1130Networking Break in Exhibition Area
-
1130 - 1200Strengthening Value Chain ResilienceTakeda's focus on resilience in the face of supply chain disruptions is crucial for ensuring the continuous supply of life-transforming treatments to patients. To achieve this, Takeda's global manufacturing and supply (GMS) division has been actively working on transforming its operations to build a more resilient, efficient, and sustainable value chain. Key elements include the simplification and harmonization of business resilience and end-to-end supply chain processes, stronger collaboration with internal and external interfaces and stakeholders and a more dynamic and proactive data-driven risk mitigation based on innovative data, digital and technology.
-
1200 - 12302024 Facility of the Year Award (FOYA) Category WinnersISPE’s Facility of the Year Awards (FOYA) is an annual program that recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, to reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. For nearly 20 years, FOYA has been recognizing innovations in the pharmaceutical industry. Join us as we announce the 2024 ISPE FOYA Category Winners for their exemplary projects.Speakers
-
1230 - 1400Networking Lunch in Exhibition Area
-
1400 - 1430FDA Regulatory Keynote
-
1430 - 1530Operations Excellence Meets DigitalOperations Excellence Meets Digital: Miss the Shift, Miss the Future – Merck & Roche Sharing Experiences The Digital Business Transformational Journey needs to be well prepared, strategically supported by senior management and all organizational stakeholders. The execution of the transformation is an interdisciplinary cross divisional and silo connecting journey. Michelangelo Canzoneri from Merck KGaA and Daniele Iacovelli from Roche have started the journey in their organizations already and will share experiences any pitfalls to ensure a successful transformation. This ranks from the upfront digital Business maturity assessment via first lighthouse projects up to a connecting the lighthouses to lightbars solid strategy which enables an accurate data driven organization.
-
1530 - 1615Networking Break in Exhibition Area
-
1630 - 1730Regulatory PanelHarmonization to Break Down Barriers to Robust Supply ChainsSpeakers
-
1730 - 1900Welcome Reception in Exhibition Area
Day 2
Wed, 17 Apr
-
0800 - 1800Registration Open
-
0900 - 0910A Word from the ISPE Foundation
-
0910 - 0940Unlocking New Possibilities with the Industrial MetaverseThe next decade will be completely transformative for companies across all industries as they embrace the possibilities of the metaverse, AI and advanced simulations to develop new products and services, enhance customer experiences, and unlock speed, agility, and operational efficiencies. The metaverse is the 3D evolution of the internet, a network of connected and persistent virtual worlds, where 2D web pages are extended into 3D spaces and worlds. Metaverse applications are already here, enabling enterprises to digitally design products, processes, and facilities in 3D and simulate, analyze, operate, and optimize them, too.Speakers
-
0940 - 1010EMA Regulatory Keynote
-
1010 - 1020Remarks from the Conference Chair and Iberia AffiliateSpeakers
-
1020 - 1100Networking Break in Exhibition Area
-
1100 - 1115Introductory Remarks
-
1115 - 1215Regulatory Preparedness for Digital TransformationPanel DiscussionSpeakers
-
1215 - 1345Networking Lunch in Exhibition Area
-
1345 - 1415Pharma 4.0™ 7th Edition Survey: Deep Dive Latest Correlation and TrendsThe Pharma 4.0™ 7th edition Survey, and its latest deep dive, aim to share the ISPE Pharma 4.0 update on maturity, enabling technology adoption, benefits, challenges and general sentiment around 4.0 from Life Science protagonists. The deep dive of the 7th edition presents an extended analysis into additional intriguing correlations and trends when analyzing current versus previous editions results together with demographics.Speakers
-
1345 - 1415Inspection Case Study from TGAInspection Case Study from the Therapeutic Goods AdministrationSpeakers
-
1345 - 1415Good Engineering Practice & Efficient Investment Management
-
1345 - 1445Implication and Opportunities of CSA on Part 11 & GAMP 5Regulatory panel discussion on the implications and opportunities of CSA draft guidance and GAMP 5 2nd Edition on 21 CFR Part 11
Since the release of the FDA draft on Computer Software Assurance (CSA), September 13th, 2023, many questions and concerns have been raised regarding the impact of the guidance on 21 CFR Part 11. Regulators will have an open discussion around the implications and opportunities that may impact the 21 CFR Part 11 while applying CSA methodology.Speakers
-
1415 - 1445Takeda's Journey to Digital TransformationIn this presentation, I will share some aspects of our organization's journey towards digital transformation. The main focus will be on building up the digital infrastructure by introducing a global Engineering Information Management System (EIMS) to be able to handle engineering data and documents in a validated platform, to automate engineering workflows such as document approval and change management, and to integrate the system with other global platforms as a mandatory foundation for digital twin (quality, validation, etc.). Key Topics to be Covered: The need for digital transformation Understanding Pharma 4.0 Leveraging Digital Technologies Overcoming Challenges Lessons learned and best practicesSpeakers
-
1415 - 1445Inspection Case Study from MHRAInspection Case Study from the Medical and Healthcare products Regulatory Agency
-
1415 - 1445Advances in Gene Editing and Facility Design SolutionsSince the discovery in 2012 that the CRISPR-Cas system can edit genes, interest in gene editing as a therapeutic has accelerated. Gene editing has the potential to provide curative therapies for some of the most severe and often fatal genetic diseases. While the CRISPR-Cas system is the most prevalent gene editing technology, others, including Transcription Activator-Like Effector Nucleases (TALENs), Zinc Finger Nucleases (ZFNs), and Base Editing have significant investment in both development and the clinic. Gene editing has applications providing therapies for chronic diseases including HIV-1, as well as oncolytic applications. In the immuno-oncology field, gene editing is critical in the production of universal allogeneic T cell therapies including T-cell Receptor (TCR) and Chimeric Antigen Receptor (CAR-T). Given the different applications of gene editing, there are multiple platforms employed for either in vivo or ex vivo delivery to patients. In turn, there are diverse manufacturing modalities in development including oligonucleotide synthesis, in-vitro transcription, viral vectors, and cell therapy. Sponsors are now addressing multi-patient, multi-modality operations under one roof. Each of these manufacturing platforms has nuances in the design that must be addressed early in facility design.Speakers
-
1415 - 1445ISPE Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd EditionWith the 3rd edition of the Biopharmaceutical Manufacturing Facilities Baseline a new standard is set. It provides the latest insights on the use of Quality Risk Management (QRM) and Contamination Control Strategy (CCS) when designing a biopharmaceutical facility to protect the product and ultimately the patient. Keeping closed processing at the core to cut the risk of (cross-)contamination at the production floor, it reviews the definition of Closed Systems by introducing the Process Zone concept providing clarity and simplicity necessary in the implementation and success of such technology. Moreover, the chapters on GMP facility layout and architecture, mechanical and electrical design and sustainability are revised and brought to current practice. The presentation will provide a structure overview of the motivation and the updates in the guideline.Speakers
-
1445 - 1515AI Applications in Quality ManagementAI Applications in Quality Management to Drive QUALITY and ImprovementsSpeakers
-
1445 - 1515PFAS and Titanium Dioxide: Where Are WePFAS and Titanium Dioxide: Where Are We – Regulatory Trends and Drug Availability Several legislative proposals stemming from the Green Deal which focuses on climate, zero pollution, chemicals, and circular economy will have a substantial impact on pharmaceutical sector operations and availability of medicines. At the same time, the Commission proposal for a revision of the general pharmaceutical legislation, specifically calls out many of these legislations. Many of these are open legislative proposals and their cumulative effects are unknown and some implementation measures can heavily compromise the EU strategic autonomy and competitiveness goals in the pharmaceutical and healthcare sector. It is essential that any decision that forms part of the EU Green Deal or chemical strategy does not have a negative impact on ensuring the access and availability of safe, efficacious medicines and vaccines to European patients. Medicine regulators must have autonomy on Benefit/Risk decision-making which needs to take precedence over other decision-making requirements when it comes to medicines. Proposing very strict and disproportionate measures related to environmental concerns may create significant risks to the availability of medicines. There is a need to balance environmental concerns with continuity of R&D, manufacturing and access to medicines in Europe. The presentation will focus on two restrictions under consideration, in particular, there is on a ban in the EU on the use of Titanium Dioxide as a food additive and provisional inclusion of TiO2 in the list of approved colours allowed for use in medicines – where it is used in up to 70 % of oral dose forms - however, the Commission will review the necessity to maintain TiO2 or to delete it from medicines by February 2025. The second focus will be on the proposal for a universal restriction on PFAS, where the objective is to ban all PFAS unless derogated. It would apply across all industries including the pharma industry. The direct impact on product and manufacturing, the “ban unless derogated” approach is creating a high supply chain risk.Speakers
-
1445 - 1515Closed Processing at Risk: A Regulatory View on Closed SystemsThe concept of closed system and closed processing had gained a lot of relevance in the last years. It is more and more recognized as one of the most robust methods to protect the drug substance and product from a potential environmental contamination. But how far are the regulatory agencies accepting and facilitating closed processing? How does recent regulatory guidance (e.g. new Annex 1) reflect the advance in closed technology? Is there a benefit in placing close processing in a central place in the contamination control strategy? In the presentation we will review the regulatory history around closed processing, when and how it came into play and the recent evolution to a more prescriptive approach. We will hear on the benefits and challenges that we will find along the implementation when designing the future manufacturing facilities. More, we will learn how to correctly interpret the regulatory requirements to avoid overdesign. The presentation is the result of the work performed within BioPhorum group, in the Closed Systems in CNC Spaces work group, that has been recently published as part of the Closure Playbook.Speakers
-
1445 - 1515Validation of Cloud Computing SaaSValidation of Cloud Computing SaaS: Navigating Client-Vendor Accountability and Supplier Qualification
This presentation will focus on the critical aspects of validation Cloud Computing Software as a Service (SaaS), focusing on the intricate dynamics of client-vendor accountability and supplier qualification. The goal will be to explore key considerations for clients such as: data security, compliance, service level agreements, outline strategies for vendors to uphold transparency, reliability and responsiveness. Additionally, there will be a highlight on the importance of thorough supplier qualification with a multidisciplinary team emphasizing on criteria such as industry experience, technical expertise and regulatory compliance. This allows for organizations to confidently navigate the complexities of the cloud computing landscape, ensuring robust validation processes and fostering mutually beneficial partnerships.Speakers
-
1515 - 1600Networking Break in Exhibition Area
-
1600 - 1630AI as an Enabler for Automated Digital Cryo-EM Image ProcessingIn this talk, we provide insights from the GAMP D-A-CH local Special Interest Group AI case study conducted together with ATEM. In this case, cryo-electron microscopy images need to be assessed, regarding quality of loads in adeno-associated viruses (AAV). Depending on cutting direction, these may appear in various shapes. While empty and full loads are easier to identify, careful assessment is required for partially filled vectors. In this collaboration, computer vision approaches were applied to support the identification of relevant structures in microscopy images and assist in the classification of these cases. We will share insights into methodological approaches, results and limitations of this application of AI and ML methodology.The talk is one sibling of its twin in the GAMP track where we provide insights from a validation perspective in lifting this process from use in non-GxP processes to GxP compliance.
-
1600 - 1630De-risking Your Aseptic Operation via Better Design from a Regulator View
-
1600 - 1630Best Practices for Digital Batch Records: eBR in Pharma 4.0Our industry is experiencing a true paradigm shift and we need to embrace change in order to capitalize on the promise of Pharma 4.0. The latest experiences with digital tools used for batch recording and digitization of GMP processes and procedures have shown significantly less effort spent in achieving compliance and decreasing cost of quality. This is because digital technologies can inherently provide compliance and finally take us out of the realm of paper documents.This presentation showcases how digital solutions provide easily accessible and interpretable documentation stored digitally and how compliance is built in, not an afterthought. Example solutions of how modern cloud based technologies capture batch record and other GMP data will be used to show what compliance looks like in the Pharma 4.0 paradigm. One of the cornerstones in these examples is the use of a risk-based approach and alignment with the CSA guidance. The presenters have used these methods and concepts in the industry and bring unique perspectives on how they can be adopted with examples and use cases. The presentation aims to educate the attendees on the inherent capabilities of digital technologies that support Pharma 4.0 and Validation 4.0.Speakers
-
1600 - 1700Project Governance - Key for Project SuccessSuccessful project governance for important, strategic projects by the managers of an organization (essential stakeholders) is one of the most important success factors for projects. Until now, the focus in day-to-day project management has been exclusively on improving operational project management. Studies in many major projects have repeatedly shown that problems in project governance have been identified as a key factor for failures.Speakers
-
1630 - 1700Leveraging Digital to Improve Manufacturing ProcessesHow Eli Lilly Italia manufacturing plant has leveraged digital technologies and advanced data analytics to improve and control end to end manufacturing processes through process mining, continuous processes anomalies detection and diagnosis, machine components predictive maintenance, process variability automated root cause analysis and self service data analytics platform adoption. The presentation will cover both strategical and practical aspects behind Eli Lilly digital journey showing, through several real use cases, how to transform data in actionable insights that enable the business process owners to improve performances and productivity finally regenerating a measurable and tangible business value (i.e. capacity increase, cost reduction).
-
1630 - 1700De-risking Your Aseptic Operation via Better Design from the industry ViewThis presentation will follow from the FDA Presentation about the regulatory View of the De-risking your Aseptic Operation. Aseptic Operations still relay a lot on manual operation which pose a high risk to the sterile product. During this presentation the Engineering Control like Barrier, Appropriate and validated transfers inside the Barrier, Stopper Transfer set up and how to de-risk this manual operation as well as automation solution will be explained and how those support the Contamination Control Strategy CCS and Contamination Control Management CCM in Aseptic Operations.Speakers
-
1630 - 1700Drug Shortage Prevention: Where are we?Speakers
-
1630 - 1700Impact Analysis of Project Risks on InvestmentCapital projects are usually an integral part of an investment and timely delivery is often critical to commercial success. We developed a methodology to determine the financial impact of a potential project delivery delay. The methodology takes uncertainties into account and can be used to objectively compare the impact of a potential launch delays for several projects.Speakers
-
1630 - 1700Leveraging GAMP®5 for Medical DevicesWith GAMP®5, second edition, software as or in a medical device is no longer excluded from GAMP®5 scope. The GAMP/ISPE concept paper “Leveraging GAMP®5 for Medical Devices” currently prepared for publication provides fundamentals and toolkit to apply the new opportunities in daily practice. Presentation will identify and introduce relevant MD standards for software as/in medical devices. GAMP will be compared with the MD standards, and equivalence is demonstrated. Standards covered in comparison with GAMP®5 are 21CFR Part 820 and ISO 13485:2016 for the quality management system, IEC 62304, and IEC 82304-1 for the software development life cycle and EN ISO 14971 concerning the application of risk management to medical device software. Based on the outcome of the comparison, a straightforward roadmap is proposed to apply GAMP in medical device context and areas offering highest possible benefit using GAMP for medical devices are identified.Speakers
-
1700 - 1730Implementing the Use of Collaborative Platforms and 360 Degree Cameras to Improve Efficiency and ProductivitySpeakers
-
1700 - 1730GxP Inspector Findings Global View
-
1700 - 1730Panel Discussion on Drug ShortagesSpeakers
-
1700 - 1730Case Study: Experience with Risk Management for Large CAPEX ProjectsMarcus will share the approach taken on risk management during the planning and execution of the Merck Biotech Development Center Project in Vevey, Switzerland. He will show the different methods applied and how these helped focusing on Quality, Budget and Schedule during the Covid period and the Supply Chain Interruptions due to the Ukraine war.Speakers
-
1700 - 1730e-Compliance Requirements for Supplier and Service Providere-Compliance Requirements for suppliers and service providersFor more than 25 years, the regulated pharmaceutical industry has experienced great difficulties with regard to the inadequate implementation of e-compliance requirements for analytical and manufacturing equipment as well as IT applications.Too often, the regulated users are not able to implement such e-compliance requirements in a reasonable and consistent way so that suppliers can improve their products. their products.Nevertheless compliance is not a one-way relationship between suppliers and customers. Compliance should be the result of an open and consistent between suppliers and regulated customers.On the one hand, regulated customers should express their needs in an appropriate manner rather than expecting "wonders" on the supplier side. On the other hand suppliers should be open and pro-active in considering e-compliance requirements in the design of their solutions and implement them.Speakers
-
1900 - 2200Networking Dinner
Day 3
Thu, 18 Apr
-
0800 - 1700Registration Open
-
0900 - 0930Enhanced Process Yield Insights Through AI Powered Data AnalyticsThe pharmaceutical industry faces never-ending challenges to drive the maximum yield from highly complex manufacturing processes. Sterling Pharma Solutions embarked on a transformative project to optimize operational efficiency and align with financial objectives. Leveraging a GMP-compliant, cloud-based platform, the project focused on strategic manufacturing improvements through data collection across a range of data sources and intermediate predictors for yield management using predictive AI models. By analyzing the production processes and identifying optimal parameters for each operation, Sterling successfully developed a deeper understanding of interrelated factors that have potential to impact yield variance. The collaboration of the project enabled insights on process variability and predictive impact on yield. Amidst industry shifts towards CDMOs, embracing digitalization and Pharma 4.0 technologies is imperative for ensuring supply chain resilience and meeting market demands. The availability of GMP-compliant AI solutions presents an opportune moment for pharmaceutical companies to transition from reactive problem-solving to proactive prediction, thereby unlocking substantial benefits in compliance, transparency, and ROI.Speakers
-
0900 - 0930FAMAR Integrated System of Flash Audits: Innovation in AuditFAMAR as a dynamically developing CDMO, actively operates in an extremely demanding legislative framework for the successful development, sustainable production and timely availability of pharmaceutical products fully compliant with the established regulations & specifications.Having as its main objective the development, production and distribution of medicinal products that improve the quality of patients’ life, it applies an innovative and flexible system of internal inspections through intensive self-assessments, so called as flash audits with more than 95 events annually. These are carried out beyond the basic legislative requirements, both in number and frequency, as well as in the scope of the areas covered, as well as the self-control and continuous improvement methodology applied.The system of internal inspections through continuous, short, focused and timely scheduled flash audits has the ultimate purpose of proactively highlighting systemic opportunities in order to achieve an early diagnosis of the root cause and to implement corrective and preventive actions.Through the continuous interaction between the auditors and the auditees, with the aim of highlighting and radically solving any detected failures, the corporate quality culture as well as data integrity is cascaded within the organization and a fundamental continuous improvement mentality is formed, actively boosting regulatory compliance.Speakers
-
0900 - 0930APQ Guidance and CAPA IntroductionThe ISPE Advancing Pharmaceutical Quality (APQ) Program has been developed by industry expert representatives, for industry use, to advance the current state of pharmaceutical quality by providing practical tools and approaches to enhance the effectiveness of the Pharmaceutical Quality System (PQS). This ISPE Advancing Pharmaceutical Quality Program is a practical framework that an organization can use to first assess the maturity and then advance the state of quality within their organization. It is a quality management maturity program that aims to identify good practices and good behaviors to assess and improve each element of the Pharmaceutical Quality System. This session will focus on an overview of the comprehensive program, highlighting the CAPA module as an example of how these guides may be applied to companies across the industry.Speakers
-
0900 - 0930Speed Presentations on Sustainability CasesSpeakers
-
0900 - 0930A Control Framework to Limit Risk of AI in GxPIn this talk, we will provide insights from a validation perspective into a real-world case study of lifting a computerized system with Machine Learning (ML) sub-system from non-GxP to GxP. This is achieved by leveraging synthetic data for the computer vision MLsub-system and applying an ML Risk and Control Framework.In the case study, the computer vision ML sub-system was used to assess and classify cryo-electron microscopy images regarding quality of loads in adeno-associated viruses (AAV). Validation of the model relied on synthetic data. We will share insights into the ML Risk and Control Framework in general (considering current regulatory trends and thinking); and more specifically into its application to the above-mentioned use case.The talk is one sibling of its twin in the Pharma 4.0 track whereby we provide insights into methodological approaches, results, and limitations of this application of AI and ML methodology.Speakers
-
0930 - 1000Unlocking Efficiency & FlexibilityUnlocking efficiency & flexibility: The Power of Modular Automation in Process Development Labs
Merck KGaA has found the key to success in modular production and is relying on an industry standard called MTP - Module Type Package (VDI/VDE/NAMUR 2658). MTP is a solution approach that enables all the equipment within a central control system to communicate independently of the typically fragmented hardware and software landscape in use. Individual work steps are encapsulated in modules, enabling researchers to rapidly and repeatedly assemble them into new applications and processes using graphical tools, sans programming expertise. Benefit: Plug & Produce: By introducing a central software platform (POL - Process Orchestration Layer), all instrument functions can be integrated automatically as MTP modules (PEA – Process Equipment Assembly). Automate lab operations: focus on experiment: The core competence of a laboratory technician, is thus once again in the foreground and not the manual integration of devices or the transfer of written experiment data into Excel tables. Paperless operations: Process values, measurement, deviations and execution log are automatically stored in electronic format, no longer manually recorded. Fast reconfiguration. Tech Transfer: The up-scaling of processes from the laboratory to production plants is streamlined, requiring no manual adjustments. The presentation will offer an overview on project timeline starting from pilot project up to the full automation of 60 fume hoods according MTP standard. We will showcase a video demonstrating the steps a laboratory engineer takes to reconfigure an experiment setup, from integrating "MTP ready" modules to process orchestration, and from control application generation to execution. This will offer a clear understanding of the real use case.Speakers
-
0930 - 1000Annex 1 & APS: Practical Approach & Points to ConsiderAPS is a hot topic & area of focus of USFDA & EU regulatory inspections. EMA added more details to Annex 1 to reduce ambiguity. The presentation will cover: What are the most common pitfalls & repeated audit findings in USFDA WLs and EU MHRA and HPRA inspections? How to design APS in compliance with updated Annex 1?Speakers
-
0930 - 1000APQ and Quality Culture
-
0930 - 1000AI Revolution in Visual Inspection Use Case with CSL BehringPharmaceutical visual inspection struggles with False-Reject-Rates (FRR), where automatic inspection machines (AVI) reject good products, demanding re-inspections by human experts. This raises quality and compliance risks, hampers production speed, and requires greater space and skilled inspection experts. In this case study, we present a technical solution which condenses and synthesizes the expert knowledge of vision specialists in AI models and makes it available to AVIs to increase the inspection decision and thus, reduces the FRR. The solution framework is machine-agnostic, applicable to any AVI, even existing ones. It comprises Edge and Cloud Layers for efficient data management and making AVIs AI-ready without any significant retrofits and requalification efforts. This enables a greater inspection performance for existing equipment and induces a positive sustainability impact. In our co-presentation we show a real-world example of applying AI to a vaccine product at CSL Behring and highlight the quality impact (Detection Rates), the economic impact (FRR) as well as the sustainability impact (Less waste, less need for new equipment). Overall, the FRR is reduced by -81% to -91% for the considered camera stations, leading to a global reduction of 65%, without sacrificing the inspection quality.Speakers
-
0930 - 1030Panel Discussion on SustainabilitySpeakers
-
1000 - 1030How Generative AI is Impacting Pharmaceutical Manufacturing
-
1000 - 1030Aseptic Transfers of RTU Containers in the Light of Annex 1The new EudraLex Annex 1 describes very prescisly the requirements how to transfer any material from lower grades to the Grade A area with a special focus on Contamination Control. With the rise of of RTU fill and finish lines the transfer methods of these ready to use (RTU) primary containers such as syringes, vials and cartrdiges gets a new focus. This presentation will highlight and compare in detail the operation, sterilty and validation prinicple of the major transfer technologies such as NTT, E-Beam, H2O2, Pulsed Light Decontamination and will putthem into the light of the new Annex 1 requirements.Speakers
-
1000 - 1030Quality Risk Management with ICH Q9R1
-
1000 - 1030Monitoring of a Validated Machine Learning SolutionMonitoring of a Validated Machine Learning Solution for Environmental Data - Artificial intelligence (AI) and machine learning covers a broad set of technologies that are increasingly being used across the Life Science Industry. Machine learning is a subset of AI and involves computers processing large amounts of data in order to build mathematical models (i.e., algorithms) based on data in order to make predictions or decisions. Regulated companies have initiated the implementation of this powerful tools to facilitate and automate processes potentially affecting Patient Safety and Product Quality. Based upon this technological approach, an automated solution for Automatic Trend Analysis has been designed and implemented to allow the automatic evaluation of the environmental trend (e.g., water points, cleanrooms) acquired from the LIMS database. On a recurring base (e.g. weekly) the system reads monitoring test data of a specific element and runs a ML-based algorithm to try and detect Out of Trend (OOT) in the trend. After the system release, its output is routinely monitored in order to ensure reliability of the OOT determination.Speakers
-
1030 - 1115Networking Break in Exhibition Area
-
1115 - 1145Achieving Value through Digital ReplicationAchieving Value through Digital Replication: A Business and Project Case Study
We are living and working in a new age of digital transformation that is driving a cultural change in the way we design and deliver projects. Digital replication is one of the most impactful changes to our industry. This delivery concept reduces capital spend through production timesaving and accelerated speed-to-market delivery on replicated facilities. This solution answers the question: How can pharmaceutical companies capitalize on the successes of past projects, apply them to their future pipeline, and realize schedule and cost efficiencies?The idea of replication allows companies to design once and build many. Automated replication is a change in execution philosophy that can generate significant cost and schedule savings, with the main benefit of reducing the time to get products to patients in need.Through a case study example of a complex, large-scale drug substance facility, we will demonstrate the value of our digital delivery model that meets regulatory requirements while delivering capacity in half the time (24m v 48m), at 50% indirect cost savings and 15% of directs or 24/15/50. We are replicating from a US to a European site using an automated, data-centric approach, and the integrated team is strictly adhering to the cloning principles during execution.Speakers
-
1115 - 1145Accommodating Multiple ATMP Modalities in the Same FacilityOver the last decade, CGT Catapult has worked with industry in the development, production and adoption of ATMPs. CGT Catapult is an independent innovation and technology organization committed to the advancement of cell and gene therapies, with a vision for a thriving industry delivering life-changing advanced therapies to the world. PM Group designed the Catapult facility and will describe a process they have developed to accommodate multiple modalities within the same facility that is starting to be used more widely within the industry. CGT Catapult will then explain how they have been able to remain compliant having received multiple GXP inspections for a range of different ATMP modalities.Speakers
-
1115 - 1145Guidance on Filter Integrity Testing for DS ManufacturingThe new revision of EudraLex Annex 1 aims to give guidance on the manufacture of sterile drug products. However, it also suggests that some of its principles and guidance could (and perhaps should) be used to support the manufacture of low bioburden biologicals (active pharmaceutical ingredients/drug substance). Manufacturing a low bioburden biologicals drug substance is subject to the requirements to mitigate the risks of viable and non-viable contaminants.Annex 1 includes a comprehensive list of criteria for designing and operating sterilizing-grade filters. The list includes an expectation that the filtration system is designed for pre- and post-use filter integrity testing (FIT).While Annex 1 is relatively explicit about FIT requirements for drug product facilities, no clear guidance is available on FIT requirements in drug substance manufacturing.Our new paper—A risk-based approach to filter integrity testing requirements for biologics drug substance manufacturers—aims to fill that gap with a risk-based, value-driven approach for FIT testing of sterilizing grade filters used to manufacture low bioburden drug substances.Speakers
-
1115 - 1215How to Manage CAPA Based on Culture Excellence and QRM
-
1115 - 1215Computerized Systems in Clinical Trials – Real World Data (RWD)/Real World Evidence (RWE) and Decentralized Clinical Trial (DCT) ConsiderationsPresentation and panel discussion on usage of computerized systems in Real World Data, Real World Evidence, and Decentralized Clinical Trial. The session will provide an opportunity to introduce 2 new sections that will be published in the new, updated GPG on Validation and Compliance of Computerized GCP Systems and Data. **60 Minute Session**Speakers
-
1145 - 1215Robotic Process Automation to Enhance Individual Case StudyRobotic Process Automation to Enhance Individual Case Study Reports. Given the huge amount of adverse event data that companies must periodically process, pharmacovigilance is one of the main areas that could benefit from robotic process automation. Currently, companies tend to manually manage case reports because the data vary in quality, structure, and format and are not easily integrated. Robotic process automation could be the answer to this problem, allowing companies to process an increased caseload while maintaining the current cost base.Speakers
-
1145 - 1215Primary Containment for Manufacturing of ATMPS
-
1145 - 1215State-of-the-Art Design & Construction of Biopharma PlantThe presentation will showcase the recently-completed facility of Teva Biotech in Ulm (Germany) intended for large-scale manufacturing of biopharmaceutical products; it implements the most up-to-date and technology in this field, providing extensive multi-product capacity for Teva. Will be presented the features of such state-of-the-art plant of outstanding dimensions and complexity, the unique choices to maximize flexibility to future-proof the capacity to manufacturing product presently under discovery/development. The presenters will also introduce the technical and project execution challenges addressed by Teva and its Partner (Wood) during design, construction and qualification according to the latest GMP, under adherence to good engineering procedures, realizing the plant under full safe conditions.Speakers
-
1215 - 1245Demystifying Generative AI – How It Works and the Challenges AheadIn this presentation, we will explore what Generative AI is and how it is used to create new, previously unseen content which transforms the pharma industry. We will break down the basics of how Generative AI works, providing a clear understanding of its inner workings. As we demystify Generative AI, we will also shed light on the challenges it faces. These include crucial issues such as data quality, model interpretability, and bias. We will also discuss the ethical considerations that come with using such advanced technology in a sensitive field like healthcare. This presentation will equip audiences with a foundation in Generative AI, enabling them to understand its potential and the hurdles it must overcome.Speakers
-
1215 - 1245ATMP Panel Discussion
-
1215 - 1245Improving Sustainability by EMPQ Based Design and OperationA large area of improvement on sustainability of cleanrooms installations is related to the HVAC (e.g. supply air volume flow) design and operation. Up till now cleanroom installations have been designed based upon fixed air change rates per hour associated to applicable cleanroom grades. However, current insights, as reflected in the recently updated cleanroom standard ISO 14644-4 (Design, Construction and Start-up) and ISO 14644-16 (Energy efficiency in cleanrooms and separative devices) provide a good option to improve. In line with these standards the EMPQ (EnvironMental Performance Qualification) data can together with ongoing EM data be very useful to assess and implement responsible and justified reductions in supply air volume flow. As the energy consumption of the fan alone varies by the 3rd power already, huge gains in design and energy consumption can be achieved. This presentation highlights this based upon an actual case study.Speakers
-
1215 - 1245GAMP: Guiding Data Integrity via Data StewardshipIn the current complex clinical data collection and processing environment, data "ownership" of a record may change as electronic records progress through the clinical data life cycle transitioning across business processes and/or between suppliers, service providers, and ultimately the sponsor introducing data integrity risks.It is the intention of this presentation to demonstrate how the application of Data Stewardship as an ethical framework can be concretely implemented in the GAMP 5 context via contracts, policies, and procedures to ensure data integrity and comprehensive data governance across the often complex clinical data life cycle that necessarily crosses multiple entities, systems, databases, and actors.Speakers
-
1245 - 1415Networking Lunch in Exhibition Area
-
1415 - 1515Bridging the Gap: Healthcare Equity in the Digital AgePowered and Led by Women in Pharma
In an era marked by rapid technological advancements, this Women in Pharma panel convenes to explore the intersection of healthcare equity and digitalization, delving into the opportunities and challenges presented by digital technologies in shaping a more inclusive and accessible healthcare landscape for women and other marginalized groups. Throughout this session, we set out to foster a comprehensive dialogue among experts representing diverse fields, gaining insights into how digitalization can be harnessed to reduce healthcare disparities and ensure that advancements benefit all segments of society. Throughout this panel we will discuss: Equitable Access: Exploring strategies to ensure that digital health tools and services are accessible to all, irrespective of socio-economic factors or geographic location. Innovation and Inclusivity: Examining how the private sector can contribute to the development of inclusive technologies that address the unique needs of diverse patient populations. Assessing the impact of public-private partnerships in fostering innovation while prioritizing healthcare equity. Policy and Governance: Analyzing the role of government policies in creating an enabling environment that promotes digital health without exacerbating existing disparities. Discussing regulatory frameworks that balance the need for innovation with safeguards against discrimination and unequal access. Patient-Centric Perspectives: Highlighting the patient experience in the digital age, with a focus on how digital tools can empower individuals while addressing issues of digital literacy and accessibility. Exploring the role of patient advocates in shaping policies that prioritize the needs of vulnerable and underserved communities. Data for Impact: Investigating the potential of health data collected through digital platforms in identifying and addressing health disparities. Emphasizing the importance of ethical data practices, patient privacy, and ensuring that data-driven interventions contribute to equitable healthcare outcomes. -
1515 - 1615Hackathon Winner Presentation
-
1615 - 1630Closing Remarks
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.
Programme Changes
Programme is subject to change. Last minute changes due to functional, private, or organisational needs may be necessary. The event organiser accepts no liability for any additional costs caused by a change of programme.
ISPE Membership Benefits
Become a member today
Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18,000 pharma professionals from around the world by becoming an ISPE Member.
Benefits include:
- Online access to select ISPE Good Practice Guides that will help you learn how to practically implement best practices and principles
- Member-only discounts on Guidance Documents, Conferences, and Training
- Pharmaceutical Engineering® magazine
- Communities of Practice access to pharma professionals in specific topics from around the world
- And more