Artificial Intelligence supporting Life Science
Join us on April 19th, 2023 at QbD, Wilrijk (B), for an exciting meeting on Artificial Intelligence (AI) in a GxP environment and how GAMP5 2nd edition can support this. This event will focus on use cases in AI supporting Life Science, and applying GAMP5 and Pharma 4.0 concepts to machine learning. Learn from experts in the field about how these cutting-edge technologies can be used to improve quality, efficiency and safety in the pharmaceutical industry:
- Discover the benefits of digital twin technology for real-time monitoring and simulation of manufacturing processes;
- Tweaking a machine learning model supporting pharmacovigilance and adverse event reporting;
- Real Time Data Assisting in Process Development and Production in Chemical Applications.
This meeting will feature a panel discussion on the use of AI and CHATGPT including Q&A. Attendees will have the opportunity to ask questions and gain valuable insights from experts on how to apply GAMP(R)5 concepts to machine learning in a GxP environment. Don't miss out on this opportunity to network with industry leaders and gain a deeper understanding of the future of the pharmaceutical industry. Register now on our website and be at the forefront of innovation!
This event is held at QbD, Groenenborgerlaan 16, 2610 Wilrijk (Antwerp), Belgium, who are so kind to sponsor the facilities, drinks and food.
Car parking: you can easily park in the nearby streets. Take 5-10 mins to walk to QbD.
By train ("Berchem Station") and/or bus "21": get off at "Wilrijk Vijverlaan" busstop right in front of the QbD office.
The event is open for both ISPE members (free of charge) and non-ISPE members. Registration is required, limited seats available.
Event Properties
| Event Date | 19-Apr-2023 13.30 |
| Capacity | 70 |
| Registered | 63 |
| Individual Price | €40.00 |
| Location | QbD |
Agendas
| 13:30 |
Welcome & registration |
| 14:00 |
Welcome by organisation and hostGAMP COP Benelux Chair - Natasja Bastiaens SIG Pharma 4.0 - Niels De Blende Host - Martijn Reniers (CIO at QbD) |
| 14:15 |
Introduction to AI/MLGAMP COP Benelux - Gerard Gorka, Bart Degroote and Frans Boeijen Introduction on Artificial Intelligence & Machine Learning - GAMP5 2nd Edition - Appendix D11 |
| 14:35 |
Use case: Digital twins built for vaccine production processesSandrine Dessoy (GSK) and Nicolas Catrysse (Siemens) A digital twin is “a real time digital replica of a physical device”, i.e. it is a digital informational construct of a real physical system that constitutes an entity of its own. A digital twin aims to mirror the life of its corresponding physical asset and utilizes state-of-the-art physical and/or hybrid models, advanced Internet of Things sensors, and AI/Machine Learning to do so. |
| 15:05 |
Sensor Data excellence and how to implement it in PharmaJonathan Boel (QbD) and Adriaan Van Horenbeek (Timeseer.AI) Data is key on the road to Pharma 4.0. What is even more important is the quality of the data. On the road to excellence the quality of data, such as sensor data needs to be assessed to help and get an understanding of what is going on. Timeseer.AI has developed such a tool with multiple algorithms to assess the quality of data. The benefits of such an approach and how to implement it in Pharma will be shared with you all in this session. |
| 15:35 |
Coffee BreakSponsored by host QbD |
| 16:00 |
Deep-learning in Good Pharmacovigilance Practices [GPvP] environment:Modelling approachBorys Berlog (UCB, AI Engineering) Deep Learning is one of the most rapidly developing machine learning techniques, in particular in Natural Language Processing field. One of the most recent examples include ChatGPT from Open AI. However its use in a regulated environment has faced many challenges due to “black-box” nature of the underpinning algorithms. In this presentation we will explain how UCB implemented and validated a deep learning based solution in a GPvP environment. |
| 16:30 |
Deep-learning in Good Pharmacovigilance Practices [GPvP] environment:Validation approachLaurence Mertens (UCB, IT Compliance) Presentation about the validation approach of the deep learning based solution, presented by Borys. |
| 17:00 |
Use case: Real Time Data Assisted Process Development and Production in Chemical ApplicationsNiels Vandervoort (Janssen Pharmaceutica) A self-driving car drives us from A to B, using a GPS calculating the ‘best’ route (short, sustainable, fast) in real time taking the real world into account (traffic, detours). Can we translate this example into chemical processing and deliver that ‘self-driving process car’ executing the chemical process in the most optimal way without operator intervention? This question was put to the test within the API small molecule pilot plants of Janssen Pharmaceutica in Geel in using a reinforcement learning agent with hybrid models to execute a solvent switch unit operation autonomous and in the most optimal way. This project was executed as part of the DAP2CHEM (Real Time Data Assisted Process Development and Production in Chemical Applications) Catalisti consortium. |
| 17:30 |
Short break |
| 17:35 |
Panel Discussion on AI/ML and the use of ChatGPTLead by Frans Boeijen and Bart Dewolf Panel: Borys Berlog, Jonathan Boel, Niels De Blende |
| 18:15 |
Q&A |
| 18:25 |
Wrap-up & closingGAMP COP Benelux Chair - Natasja Bastiaens |
| 18:30 |
Dinner / networkingSponsored by host QbD |
| 19:30 |
End |
Speakers
Natasja Bastiaens
GAMP COP Benelux - Chair
Natasja is a demonstrated people leader with 20+ years of experience in the life science industry covering different roles (Team Lead, Project Manager, Coach, Compliance Officer,...) and expertises (CSV, IT Compliance, Cyber Security,...) in different GxP environments. She`s part of the ISPE GAMP COP Benelux Board since 2018.
Jonathan Boel
Head of Software Solutions and Services - QbD
Jonathan has more than 10 years of experience in computer system validation, data integrity and general QA activities for different GxP and medical device industries. Jonathan is also a Trainer, certified auditor and Senior Project Manager at QbD.
Adriaan Van Horenbeek
Chief Customer Officer - Timeseer.AI
Adriaan holds master degrees in electromechanical engineering and industrial management, and received a PhD in mechanical engineering at the University of Leuven for research on predictive maintenance. He has more than 10 years of experience in making impact with data and advanced analytics in manufacturing.
Nicolas Catrysse
Siemens
Nicolas is covering a wide range of Digitalization Solutions for the process industry. Mainly focusing on the Digital Process Twin, Digital Plant Twin & manufacturing operation management. He's collaborating with people from different organizational units to deliver solutions on the roadmap towards a Digital Enterprise.
Borys Berlog
AI Engineering Lead - UCB
Borys is an AI Engineering Lead at UCB (since 2020) and his work is focused on implementing engineering best practices for analytics solutions. He has more than 10 years of experience in different IT domains with a focus on engineering and machine learning. He holds a Master degree in Physics (National Technical University of Ukraine) as well as a Master in AI (KU Leuven).
Laurence Mertens
IT Compliance - UCB
Laurence is a bio-engineer, graduated in 2011. She joined UCB as an IT Compliance Lead. The implementation of a pharmacovigilance system using deep-learning allowed her to conceptualize and implement a validation methodology applicable to that system. She is now in charge of advanced analytics project in the laboratory and manufacturing scope.
Sandrine Dessoy
GSK
Sandrine joined GSK Vaccines 25 years ago. After working in development and scale-up, process modelling and evaluation of new technologies, she now leads digital twin projects in Technical R&D. Sandrine holds a Chemical Engineering degree and a Master in Molecular Biology and Biotechnology from Université Libre de Bruxelles.
Niels Vandervoort
Janssen Pharmaceutica
After his graduation as MSc Chemical Engineer (2013 KULeuven) he started as automation & application engineer in the petrochemical industry. He joined Janssen in 2015 where he gained experience in pharmaceutical development, production and automation. Today he is Data & Systems lead for the API small molecule pilot plants.
Frans Boeijen
ISPE GAMP COP
Frans is an experienced trainer on validation of IT systems and data integrity in life science. He is an active member of GAMP COP Benelux SC since 2008.
Gerard Gorka
ISPE GAMP COP
Senior Project manager & Consultant within life science. Vice Chair of GAMP COP Benelux.
Bart Degroote
ISPE GAMP COP
Bart combines his interest in science and IT in his job as senior consultant. His expertise lies in implementating and validating computerised systems in a GMP environment. Besides this he also is a trainer in CSV and Data integrity.
Jacques Godelaine
SIG Pharma 4.0 Lead
ISPE Belgium Affiliate SIG Pharma 4.0@work wants to focus on sharing ideas, opinions and experiences of current business practices related to topics like Digital Architecture, Artificial Intelligence, Machine Learning, MES connectivity, etc.
Bart Dewolf
ISPE GAMP COP
Global Digital Quality Lead - Auditing and Compliance at UCB, and member of GAMP COP Benelux.
