Preliminärt program 29 april 2025
10:00 Välkommen
IVDR status och vad krävs vid övergång
Michael Johansson, Consultant Prevas
Targeted Evaluation av IVDR – Läkemedelsverkets perspektiv på möjligheter och utmaningar framåt
Helena Dzojic Enhetschef Enheten för medicinteknik, Läkemedelsverket
12.00 Lunch
AI Act, technical documentation, expectations etc
Charlotte Hess, BSI
Clinical Performance Evaluation
Pascal Skoglund, Consultant Plantvision
Cybersecurity, NIS 2
Plantvision or Prevas
Sustainability
David Frydlinger, Advokat, Cirio
17.00 Avsluting och mingel
Välkomna!
For Inmas session we would for example suggest the title: ‘preparing for the AI adoption in a regulated environment’. Ana will talk about IVDR lessons learnt and Technical File requirements, if you agree and think that this is of interest to the audience – in our experience these topics were always highly appreciated by attendees.
Prevas
Don Francis
Prevas
Helena Dzojic
Läkemedelsverket
ZZZZZ
BSI
Pascale Skoglund
Plantvision
Therese Hazelius
VD Swedish Labtech