EUCRAF is pleased to announce the names of the speakers of Seminar 5. This seminar provides the specific considerations for the development and authorisation of medicinal products for children.

Dr. Siska De Moor from MSD and Dr. Genevieve Michaux from Covington & Burling LLP are the Course Leaders of Seminar 5.

Dr. Siska De Moor speaks on the EU Regulation No 1901/2006 on medicinal products for paediatric use as well as on implications of the EU legislation for the pharmaceutical industry:perspectives, challenges, opportunities and demonstrates a case illustrating PIP practice with discussion.

Dr. Angelika Joos  from MSD introduces the regulation for medicines in children in other regions with focus on the USA,

Dr. Daniel Brasseur, a PDCO Chair, Federal Agency for Medicines and Health Products, Belgium, holds a presentation about the EMA and the Paediatric Commitee (PDCO), the scope of the Paediatric Investigation Plan (PIP) and the list of paediatric needs and priority list of off-patent medicines. Further he gives an insight into the publication of clinical trial results and the development of regulatory guidelines on considerations of drug development in children.

Dr. Avril Mankel from NDA Regulatory Services explains the preparation of the Paediatric Investigation Plan (PIP).

Dr. Genevieve Michaeux gives a talk about PIP-related legal aspects.

Dr. Ashley Strougo from Astellas Pharma speaks about the considerations for developing and executing the PIP and paediatric networks.

Dr. David M. Cross (formerly Pfizer Global Research and Development UK) presents the topic: Juvenile animal studies.

Dr. Jörg Breitkreutz from the University of Düsseldorf presents the requirements on paediatric drug formulations.