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The Legal, Ethical, and Commercial Issues Impacting the Development and Accessibility of Pediatric Medicines

Track:
Public Policy/Health Care Compliance/Law

Day & Time:
June 18, 8:00AM - 9:30AM (Pacific Standard Time)

Session Number:
314

Room Number:
6E

Level:
Intermediate

Type:
Forum

Title:
The Legal, Ethical, and Commercial Issues Impacting the Development and Accessibility of Pediatric Medicines

Chair(s):
Marie Isabel Manley, LLM
Partner, Head of the Regulatory Legal Group
Bristows LLP, United Kingdom

Description:
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(s):
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.

Presentation(s) & Speaker(s):
What Have Been the Benefits and Lessons Learned After Five Years of the Pediatric Regulation?
Marie Isabel Manley, LLM
Partner, Head of the Regulatory Legal Group
Bristows LLP, United Kingdom

Impact Of The EU Pediatric Regulation
Klaus Rose, MD, MS
Chief Executive Officer
klausrose Consulting, Switzerland

The EU Pediatric Regulation: The Regulator's Perspective
Karl-Heinz Huemer, MD, PhD
Clinical Assessment Safety and Efficacy
Austrian Medicines and Medical Devices Agency (AGES), Austria