Online – 17 May, 2022, 10.00 PM to 5.00 PM (CEST)
Rationalizing optimal Dosing for use in Children: Current Situation – Potential Solutions – Activities needed Science for Children at the border between paediatrics, regulatory affairs
“Children are no small adults with respect to the treatment with medicinal products” – as stated by WHO. This understanding has been the basis for the initiative of the European Commission to build the Paediatric Committee (PDCO) as a scientific board of the European Medicines Agency (EMA).
A Paediatric Regulation came into force in the European Union (EU) on 26 January 2007. Its objective was and still is to improve the health of children in Europe by facilitating the development and availability of medicines for children aged 0 to 17 years. 15 years later we have to realize, that the results are moderate.
This eSymposium will give opportunity to analyse the reasons and to present prospects for alternatives to establish proof of safe and efficacious herbal medicines for children’s use.
The eSymposium is intended to be the starting point to discuss actions to be initiated as soon as possible to find suitable ways for establishing- ing rationalized dosage regimes for phytotherapeutics for the use in children.
This eSymposium is a joint initiative of the Society of Medicinal Plants and Natural Products Research (GA), the Gesellschaft für Phytotherapie (GPT), and the Foundation Plants for Health (PfH) with the aim to facilitate research in this neglected area of healthcare, including future funding opportunities of research for phytotherapeutics in children.
|9:30 h. Arrival and Preparation|
10:00-11:00 h. Session A: Impulse Cluster
Welcome Prof. Dr. Rudolf Bauer, University of Graz, Austria
|10:05-10:20 h. The academic viewpoint. Prof. Dr. Karin Kraft, University of Rostock, Germany Prof. Dr. Judith Rollinger, University of Vienna, Austria|
|10:20-10:35 h. The paediatric viewpoint. Dr. med. Karl Rüdiger Wiebelitz, Perleberg, Germany|
|10:35-10:50 h. The regulatory viewpoint. Dr. Reinhard Länger, Austrian Federal Office for Safety in Health Care, Vienna, Austria|
|10:50-11:00 h. Moderated Discussion|
11:15-13:20 h. Session B: The International Situation
Chair: Prof. Dr. Michael Heinrich, UCL School of Pharmacy, London, U.K.
|11:20-11:40 h. The situation in the DACH region (Germany, Austria, Switzerland). Dr. Birka Lehmann, Paediatric Committee (PDCO) of EMA|
|11:40-12:00 h. The situation in U.K. Dr. Melanie Pires, and Dr. Liz Griffiths, Medicines and Healthcare Products Regulatory Agency, London, U.K.|
|12:05-12:25 h. The situation in Spain. Montserrat Mesegué, MD, Spanish Society of Phytotherapy (SEFIT), Barcelona, Spain|
|12:25-12:45 h. The situation in Eastern Europe. Dr. Bernd Roether, Bionorica SE, Germany|
|12:45-13:00 h. Moderated Discussion|
14:00-16:45 h. Session C: Potential Solutions
Chair: Prof. Dr. Andreas Hensel, University of Münster, Germany
|14:00-14:20 h. Best practice examples for paediatric dosages for children from HMPC. N.N.|
|14:25-14:45h. Safety aspects within ICH, lessons learned from dosage for children for chemical entities. Dr. Robert Skip Nelson, Johnson & Johnson, Member of ICH E11A Group, Senior Director, Pediatric Drug Development (CHILD), Pediatric Strategy Lead, Pediatric Development Team, Immunology|
|14:50-15:05 h. Methods to predict adequate dosing in children using knowledge from adults. Prof. Dr. Georg Hempel, University of Münster, Germany|
|15:10-15:30 h. Controlled clinical studies with children – a review on European level. Prof. Dr. Karin Kraft, University of Rostock, Germany|
15:35-16:05 h. PhytoVIS data base as a pharmacoepidemiological tool for getting real world data on paediatric use. Prof. Dr. Karen Nieber, University of Leipzig, Germany; Dr. Olaf Kelber, Steigerwald Arzneimittel GmbH, Bayer Consumer Health, Germany
|16:10-16:45 h. Moderated discussion, wrap-up, summary and conclusion All Speakers of the Symposium – one key message in one sentence per speaker! Prof. Dr. Andreas Hensel, University of Münster, Germany|
Registration (Free of charge)