This congress of Paediatric Drug Development will give you great insight on how to prepare comprehensive clinical studies and writing a Paediatric Investigation Plan

Die auf englisch gehaltene Fachtagung für pädiatrische Medikamentenentwicklung erörtert Anforderungen durch die geänderte EU-Richtlinie der EMEA. Dazu werden Erfahrungsberichte und Lösungsansätze präsentiert.

Preparing clinical studies and clinical trials and conducting successful clinical trials

The industry is faced with internal and external challenges regarding the strategic planning and development of the Paediatric Investigation Plans, the integration of paediatrics into the overall drug development process and issues surrounding the inevitable paediatric clinical trials.

Experts help you to reach global paediatric standards in clinical trials

The 3rd congress for Integrated Paediatric Drug Development will help you to develop the Paediatric Investigation Plan that meets the FDA, EMA regulations. More over you will learn about the specific requirements from pharmacology for the successful implementation of your trials in neonates, infants and children to avoid high failure rates.

Gain insight in ongoing paediatric studies on the Interactive Workshop Day

Workshop A Designing a successful PIP that complies with the EU regulation and EMA/PDCO specification
Workshop B Pharmacokinetics in neonates, infants and children
Workshop C Practical considerations in regards to paediatric studies: design, structure, strategy and implementation
Workshop D Outsourcing of paediatric studies: How to optimise the cooperation in developing the PIP

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