Regulatory Affairs

Regulatory Rapporteur – September 2025

September 2025 – Contents

Reimagining product information

Product information: An overview

The EMA/NCA electronic product information initiative: Engagement, implementation and vision for the future

Electronic patient information: Results of the e-PIL pilot from Belgium and Luxembourg hospitals

What could the future of labelling look like? The Gravitate-Health story

Translating real-world needs into digital medication tools: Good practices for co-creation with patients

Digital transformation of global regulatory affairs: Then, now and next

Target product profile and product profile characteristics for labelling during drug development

September 2025 – Contents
Reimagining product information
Product information: An overview
The EMA/NCA electronic product information initiative: Engagement, implementation and vision for the future
Electronic patient information: Results of the e-PIL pilot from Belgium and Luxembourg hospitals
What could the future of labelling look like? The Gravitate-Health story
Translating real-world needs into digital medication tools: Good practices for co-creation with patients
Digital transformation of global regulatory affairs: Then, now and next
Target product profile and product profile characteristics for labelling during drug development

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