DHI TO(al)K: Al in Regulatory: From ePI to HTA

We are pleased to invite you to our upcoming event from the DHI TO(al)K series, dedicated to fostering knowledge exchange and building a sustainable digital health community.

This time, we will focus on an increasingly relevant and strategic topic for the pharmaceutical sector, the regulatory environment, and access to innovation:
the role of artificial intelligence in the context of Electronic Product Information (ePI) and Health Technology Assessment (HTA).

➡️ During the event, we will explore how AI is beginning to transform the way regulatory and scientific information is created, structured, and used, as well as the new opportunities it opens up for health technology assessment and evidence generation.

A special focus will be placed on EMA documents and guidance related to the use of AI in this specific field, while the EU AI Act will be mentioned as part of the broader context, without being the main focus of the discussion.

Our speakers will be:

🎤 Maria Dimitrova, President of ISPOR Bulgarian Chapter and Board Member of the Bulgarian Association of Pharmacoeconomics – Professor at the Department of Organization and Economics of Pharmacy, Faculty of Pharmacy, Medical University of Sofia, with academic expertise in health economics, patient involvement in HTA, and healthcare digitalization.

🎤 Petko Konakchiev and Gergana Semova, founders of PharmDedict – established in 2007, the company provides services in the fields of regulatory affairs, pharmacovigilance, and market access for companies in the pharmaceutical, biotechnology, medtech, and nutraceutical industries.