Artificial Intelligence in regulated industries
Artificial intelligence (AI) or machine learning (ML) is not a new concept. Using AI to determine individual insulin doses for diabetics is just one of many use cases that have already reached patients.
Technological advances in recent years have made it much easier to develop such applications. As a result, a wide range of potential applications are being discussed. On the other hand, there are uncertainties regarding the regulatory classification of such solutions.
PTS is therefore offering a special training course for those who want to learn the basics and practical use cases of artificial intelligence from experts and government representatives.
Regulatory requirements and AI-specific approaches
Regulatory authorities and similar bodies have also been dealing intensively with the topic for several years. Initial discussion papers have led to concrete approaches. The recently updated edition of GAMP 5 can be seen as a catalyst that will accelerate this development.
German experts have also contributed to recommendations for action in internationally published articles. Some of these experts, such as Thescon CEO Ingo Baumann and Dr. Arno Terhechte from the Regierungspräsidium Münster, will participate live in this hybrid training.
AI/ML as an opportunity and a challenge
Especially in the field of drug development and the optimised control of production and monitoring processes, AI/ML applications can contribute to more efficient and effective workflows.
But can AI/ML techniques be validated?
Take the opportunity to learn and understand general principles and application types.
Insight into the current situation and discussion with experts
Discuss with renowned experts how regulatory requirements for AI/ML systems can be implemented in practice and what specifics need to be considered.
Ingo Baumann, Rolf Blumenthal, Martin Heitmann and Dr Arno Terhechte will give you an insight into current developments and discuss specific questions such as
- What can AI do and what types of applications are supported?
- The importance of data in AI applications
- Software development lifecycle and quality assurance
- Patient safety and AI, how do they fit together?
- Authorities’ perspective on AI
- Use cases
- Discussion with participants
The training will take place on 16/03/2023 between 09:00 and approx. 17:00 as a hybrid event in Münster or remotely.
Please follow the link below to register for the special training: