DIA Hosts Key EMEA PDCO Representatives to Discuss EU Paediatric Regulation

The Drug Information Association (DIA) in Europe, in collaboration with the European Forum for Good Clinical Practice (EFGCP) Children’s Medicines Working Party, will host the first joint 3rd Paediatric Forum & EFGCP Children’s Medicines Working Party 5th Annual Conference: Integrating Paediatrics into Drug Development – From Concept towards Reality, October 27-28, 2009 in London, UK.

This forum will provide an opportunity for all stakeholders interested in the framework and practical aspects of paediatric medicines, including updates on how the EU Paediatric Regulation impacts drug development in practice, scientific aspects for developing paediatric research and development programmes, and how to use the existing paediatric research infrastructure to maximise the benefit for patients. Session topics will include:

• EU Paediatric Regulation, Experience and IP Aspects
• Generation of Paediatric Investigation Plans
• Non-Clinical Studies for Paediatric Drug Development
• Innovative Paediatric Formulations
• Safety Aspects of Paediatric Clinical Trials – Outcome Measures of Paediatric Pharmacovigilance in the EU-RMP
• Design and Facilitation of Paediatric Clinical Trials
• Partnership with Paediatric Societies and Networks
• Drug Development for Treatment of Rare Diseases
• Paediatric Oncology
• First experiences with the PIP appeal before the European Court of Justice

“The DIA in Europe and the EFGCP Children’s Medicines Working Party are pleased to announce their first joint meeting,” says Programme Committee Member Gesine Bejeuhr, Regulatory Affairs/Quality, vfa Researched-Based Pharmaceutical Companies, Germany. “The confererence will provide updates on paediatric regulations and offer a unique opportunity for attendees to meet EMEA, regulatory and drug development professionals from national health authorities and industry, academia and leading paediatricians to exchange experience and evaluate how the EU Paediatric Regulation impacts drug development in practice.

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Attendees are encouraged to arrive in London one day earlier to meet leading European regulators at the DIA/EMEA/CMD Conference on Variations on October 26. Speakers from the European Commission, the EMEA, CMD, and industry will give an overview of the new procedures content of the variation regulation, the Commission guidelines on the procedures and the categorisation details, as well as further practical implementation guidance.

For more information, please click here.

About the Drug Information Association (DIA)
DIA serves more than 30,000 professionals involved in the biopharmaceutical industry and regulatory affairs worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China, the Association is led by its volunteer-based Board of Directors and executive management team. For more information, visit www.diahome.org or call DIA in Europe on +41 61 225 51 51

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