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Follow on Google News | Exclusive Interview with Global Head of Maternal & Paediatric Regulatory Policy, NovartisSMi speaks to it's keynote presenter about Paediatric Regulation in the run up to the 8th annual conference on Paediatric Clinical Trials
By: SMi Group 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 http://www.smi- 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: “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 http://www.smi- PAEDIATRIC CLINICAL TRIALS 31st March - 1st April 2014 The Kensington Close Hotel London UK http://www.paediatric- End
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