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WHICH EU REGULATORY RULES FOR TELEMEDICINE, EHEALTH AND MHEALTH? HOW CAN INNOVATION BE ENCOURAGED?
Session Chair(s)
Erik Vollebregt, JD, LLM
Partner
AXON Lawyers, Netherlands
Learning Objective : Explain current and near future EU legislative initiatives in eHealth, mHealth and associated software (software as medical device or algorithm for companion diagnostics) Show interfaces and pressure points between medicinal products regulation, eHealth and mHealth regulation & medical devices law
Speaker(s)
European Commission Overview of the Importance of and Investment in eHealth and mHealth for Future Healthcare Sustainability
Tapani Piha
FIPRA, Belgium
Special Adviser to the Finnish Ministry of Social Affairs and Health Former Head
Action Underway to Address Regulatory Needs for mHealth and eHealth to Encourage Innovation, and the Impact on Combination Product Manufacturers
Marielle Fournier, PharmD
Voisin Consulting Life Sciences, France
Senior Director, Medical Devices and Combination Products
How to Manage IT, Telecommunications Personal Data Rules and Software Regulatory Requirements in the EU and Global Environment, including Case Studies
Erik Vollebregt, JD, LLM
AXON Lawyers, Netherlands
Partner
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