Paediatric legislation: Challenges and Impact on Drug Development

EU regulations on paediatric drug development are becoming more and more complicated and pharmaceutical companies have to prepare more robust and detailed paediatric investigation plans to ensure the success of their clinical trials
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Nov. 30, 2012 - PRLog -- SMi’s 7th annual conference on Paediatric Clinical Trials will discuss new EMA policies and guidelines on paediatric investigation plans as well as focus on clinical trial design and how the industry can overcome practical issues. With an insight into latest developments and formulation strategies this conference will present attendees with an in depth overview into the paediatric sector.

SMi is pleased to confirm Klaus Rose, Managing Director, klausrose Consulting as a speaker at the upcoming event

He will address the background of EU & US paediatric legislation, scientific & operational challenges of the Paediatric Investigation plan (PIP), how to get better medicines for children vs medicines for adults developed in children and a tentative assessment of the impact of the EU legislation

This exciting conference will provide the perfect platform to bring together key opinion leaders who will share their experiences and best practices. You will also have an insight into the latest paediatric vaccine development, safety and post-licensure studies as well as the monitoring of long term effects.

By attending this conference you will have the opportunity to
•   Discover novel strategies for patient recruitment and retention and overcome obstacles in paediatric clinical trial design

•   Evaluate benefits of locating clinical trials in emerging markets and new EMA polices
and guidelines on Paediatric Investigation Plans (PIP) with members of the PDCO

•   Understand a patient representative perspective and hear the latest in paediatric vaccine development from industry experts

•   Analyse formulation development including a regulatory focus from GSK and Astellas

•   Overcome difficulties in ethic committees in Paediatric trials and develop large phase and multi-centre clinical trials

For more information visit
Or contact Jonathan Collins on +44 0 207 827 6734 or email
Source:SMi Group
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