Date:
October 9 & 10, 2023
Language:
Location:
Abstract:
Ever since ChatGPT and Bard, artificial intelligence (AI) has entered the mainstream. Opinions range from absolute euphoria to predictions of the end of humanity. The foundations of AI were laid many years ago and can now be implemented on a large scale thanks to the massive computing power available. The topic has also made its way into the pharmaceutical landscape. The first applications have gone live. An interesting question here is whether and how this technology is compatible with pharmaceutical regulations, specifications, and the expectations of regulatory authorities.
Why should you attend this event?
- You will learn the basics of AI/ML and their applications in the GxP environment
- How can fundamental pharmaceutical principles—such as risk management and qualification/validation—be applied to AI? You’ll get a first look at some initial approaches!
- Have the relevant pharmaceutical regulations been adapted to this new technology, and what does an inspector expect to see during an inspection? Initial concepts will be presented!
- In case studies, pharmaceutical companies are showcasing initial practical and real-world approaches to the use of AI
wega will be represented by two courses during the webinar:
Data Science as the Foundation for AI
Monday, October 9, 2023
- Prerequisites for AI: Data Governance, Data Science, Data Literacy, FAIRification.
- Special Features in the Lab
- Lack of standardization, lack of connectivity.
- Opportunities Through Standards: AniML, SiLA
- Special Considerations in Clinical Development
Case Study: AI in the Medical Device Industry
Tuesday, October 10, 2023
- Introduction to Regulations Governing Medical Devices
- AI in Medical Technology:
- Patient risk: more direct than in the pharmaceutical industry?
- Reality, Not the Future: FDA List of Approved Devices.
- AI Guidelines:
- AI & Cybersecurity (ENISA Guideline)
- NMPA Guidelines on AI
- Examples of use cases:
- Electrocardiogram Analysis Using AI
You can find more details about the event here.
The Speakers:
Christophe Girardey
Managing Director and Head of the CSV & QA Department at wega Informatik AG.
He works as a CSV consulting expert on many different projects, primarily in German-speaking countries.
He places a special focus on laboratory data systems (LIMS, chromatography data systems, Laboratory Execution System) and helps customers implement the best solution from various perspectives (efficiency, compliance, data integrity).
In addition, he helps many clients make the most of agile methodologies in a GxP environment.
Nicolas Schaltenbrand
Managing Director and Head of Clinical Development Informatics at wega Informatik AG, Switzerland.
Nicola’s professional background is based on dual expertise as a clinical operations data specialist and an IT professional.
Nicolas has spent more than 25 years in pharmaceutical/clinical development, business, IT consulting, and service delivery. He has significant experience in the development and implementation of clinical information systems and technologies, with a particular focus on cloud environments and international outsourcing business models related to clinical trials.
Nicolas speaks the language of both clinical scientists and IT experts and can easily translate complex clinical processes into operational reality.
He is interested in improving efficiency in the life sciences industry through machine learning and artificial intelligence.