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The Legal, Ethical, and Commercial Issues Impacting the Development and Accessibility of Pediatric Medicines
Session Chair(s)
Marie Manley
Partner, Head of EU and UK Life Sciences (UK), Sidley Austin LLP, United Kingdom
This forum will assess the European Commission’s five-year report on the performance of the pediatric regulation and identify from a legal and ethical dimension the strengths and weaknesses in the operational structure.
This forum has been developed by the DIA Legal Affairs and Ethics and the Medicines Lifecycle Communities.
Learning Objective : Assess the ethical considerations relevant to the EU legal framework on pediatric medicines; Describe the EU legal framework governing pediatric clinical research; Describe the system of rewards and incentives within the EU Pediatric Regulation; Identify benefits and weaknesses of the existing regulatory system; Consider if the current legal framework is appropriate to govern pediatric medicine.
Speaker(s)
Marie Manley
Partner, Head of EU and UK Life Sciences (UK), Sidley Austin LLP, United Kingdom
What Have Been the Benefits and Lessons Learned After Five Years of the Pediatric Regulation?
Klaus Rose, MD, MS
Chief Executive Officer, klausrose Consulting, Switzerland
Impact Of The EU Pediatric Regulation
Karl-Heinz Huemer, MD, PHD
Clinical Assessor, Scientific Office, Austrian Medicines and Medical Devices Agency (AGES), Austria
The EU Pediatric Regulation: The Regulator's Perspective
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