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Leading international experts are organizing a new high-level two-day meeting about the interdisciplinary challenges faced in pediatric drug development. The plan is for the meeting to become an annual event. Called ?Development of Medicines for Paediatric and Rare Diseases,? the conference will take place in Basel, Switzerland, on?February 3-4, 2015
Leading international experts are organizing a new high-level two-day meeting about the interdisciplinary challenges faced in pediatric drug development. The plan is for the meeting to become an annual event.
Called “Development of Medicines for Paediatric and Rare Diseases,” the conference will take place in Basel, Switzerland, on February 3-4, 2015. Longstanding enthusiasts Prof. Johannes van den Anker, MD, PhD, Professor of Paediatric Pharmacology and Chair, Department of Paediatric Pharmacology at the university hospital af Basel, Switzerland, and Klaus Rose, M.D., managing director of klausrose Consulting in Basel, are the heads of the organizing committee.
Among the program highlights will a presentation about the regulatory view on pediatric legislation, including its achievements and limitations, to be given by Dirk Menzer, chairman, EMA Paediatric Committee (PDCO).
“Awareness of the value of new medicines for children and adults has increased over the past decades, partially as a result of US and EU legislation on pediatric and orphan diseases. However, pediatric clinical practice has changed less than had been hoped for, and an initial enthusiasm has been replaced by a more realistic assessment,” stated the organizers.
European Union and U.S. orphan and pediatric legislation is intended to promote research in children, but the PDCO will block new drugs without an approved pediatric investigation plan (PIP), and the procedure can take about a year. The legislation has created pressure to develop child-adapted formulations, pediatric dosing recommendations, age-adapted preclinical safety and pediatric clinical safety and efficacy data for new drugs that are predominantly developed for adults, they continued.
“After 8 years in force, first assessments range from asking for tougher pressure on industry to questioning if worldwide drug development for children can be successfully improved by giving almost unlimited power to an EU committee,” they added.
The conference will provide an update on both state-of-the-art methodology and operational challenges in research and development. All the key players will be represented, and the interactive format will allow a hands-on exchange of ideas and experiences. The event aimsto re-evaluate what is needed for more progress in the development of treatments for both pediatric and rare diseases.
For organizational questions, contact [email protected]. For content questions, contact Johannes van den Anker ([email protected]) and Klaus Rose ([email protected]). For sponsorship information, contact Martin Austin ([email protected]).