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Exclusive Interview with Global Head of Maternal & Paediatric Regulatory Policy - Novartis

Paediatric Clinical Trials | 31st March and 1st April 2014

SMi speaks to some of their key note presenters about paediatric trials and regulations in the run up to the 8th annual conference on Paediatric Clinical Trials

A more cohesive international regulatory collaboration would be expected to lead to minimization of duplicative or unnecessary studies...
— Novartis
LONDON, LONDON, UNITED KINGDOM, February 11, 2014 / -- SMi invites you to attend the 8th annual Paediatric Clinical Trials conference, taking place in London on 31st March and 1st April 2014.

We are very grateful to our keynote speaker, Christina Bucci-Rechtweg, Head of Maternal & Paediatric Regulatory Policy from Novartis, for taking time out to give us her views on the biggest challenge for paediatric drug development, opportunity for global harmonisation of paediatric clinical trial regulation and lessons learned from the FDASIA case study.

“A more cohesive international regulatory collaboration would be expected to lead to minimization of duplicative or unnecessary studies and foster innovation in both the technical and clinical development realms to address the unmet medical needs of children”

To read the full interview you can visit the download centre at

Christina will be joined at the event by Novartis Global Scientific Affairs Senior Expert, David McIntosh, who will be presenting on vaccine trials verses antibiotic trials. When asked about his upcoming presentation, David commented:

“Whether it is an adult with a serious bacterial infection or a child with such an infection, it is likely that antibiotic treatment will be necessary. But with increasing antibiotic resistance and a decreasing pace of antibiotic development, vaccines against healthcare associated infections provide an opportunity not only to prevent infection but also to decrease antibiotic resistance. The talk on “Vaccine Trials Versus Antibiotic Trials” will discuss the pros and cons of prevention versus cure, providing examples of the role of vaccines in decreasing antibiotic resistance. Key randomised controlled vaccine trials will be discussed and contrasted with key antibiotic trials – the risk of failure will also be highlighted.”

To hear more about the fundamental aspects of Paediatric Clinical Trials with senior decision makers from the industry, those interested can register to attend the event at

The download centre will be updated with new content on a regular basis. For current updates and further interviews click here.

31st March - 1st April 2014
The Kensington Close Hotel
London UK

Teri Arri
SMi Group Ltd
+44 (0)20 7827 6162
email us here

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