Artifical Intelligence in Regulatory Affairs

Artifical Intelligence in Regulatory Affairs
Artificial intelligence (AI) is evolving rapidly and becoming an increasingly important tool in the life science sector. For regulatory functions within the pharmaceutical and medical device industries, AI offers new opportunities to streamline workflows, improve the quality of regulatory documentation, and support strategic decision-making. At the same time, the use of AI necessitates appropriate governance, data quality, transparency, and compliance with regulatory requirements. This evening offers an excellent opportunity to learn more about how AI can be applied to regulatory work. We will also hear the latest about TOPRA. Open to anyone who works with and is interested in regulatory questions for pharmaceuticals and medical devices.
In person event - free for TOPRA IN Sweden members and employees of the Swedish MPA

Event begins 6pm Swedish local time

Program

18.00 – 18.30                The evening begins with light refreshments

18:30 – 18:35                Introduction, Alenoosh Abedi, MPA

Alenoosh Abedi                   1 18:35 – 19:05  How AI is used at the Swedish Medical Products Agency, Kim Sheerwood, MPA

- Regulus
- AI in product information
- Experiences

19:05 – 19:35   AI support for pharmaceutical companies, Anna Koptina, AI4RA

- How companies can use AI in regulatory work
- Some examples
-  Experiences

Short Break

19:50 – 20:10   Practical implications of the EU AI Act for medical devices, Inma Perez Ruiz, BSI (presentation in English)

- Setting the scene: AI in regulated sectors
- EU AI Act - what matters in practice
- How BSI supports organisations

20:10 - 20:30    AI for Regulatory Roles in MedTech, Marcus Emne, Hoodin

- Practical application of AI
- Demonstration of real-world scenarios
- Practical insights and experiences                                                         

20:30 – 20:40  TOPRA news - Margareth Jorvid, volunteer

                                               Time for Questions 

21:00 Close                         

 
When
05/10/2026 18:00 - 21:00
Where
Folkuniversitetet, Bergsbrunnagatan 2, 753 23 Uppsala 753 20 UPPSALA SWEDEN
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