Regulatory Authorities and Ethics Committees: Perspectives from Europe for Pediatric Drug Development

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Toronto, Canada (PRWEB) August 12, 2012

Join speakers Daniel Brasseur, MD, PhD, Chairman of the Paediatric Committee (PDCO) at the EMA, and Petra B. Knupfer, MD, MBA, managing director of the ethics committee of the medical association of Baden-Württemberg, Germany, and our moderator, Kathy Bohannon, Principal Strategist, Pediatrics, INC Research, for a 60 minute webinar session that will address key regulatory expectations and the role of ethics committees in pediatric development, followed by a live Q&A period with the audience.

Regulations have evolved in recent years for pediatric requirements in drug development, with key roles involving regulatory authorities and ethics committees. A recent survey conducted by the EMA among European ethics committees indicated that they have a limited understanding of the European pediatric regulatory framework. Furthermore, there is still limited awareness of ethical issues related to pediatric research and of involvement of ethics committees, especially in terms of training, education and qualifications to assess protocols for pediatric clinical trials. These same issues can extend to the sponsor community, the negotiation of pediatric investigation plans (PIPs) and the design of clinical trials as well as protocol details.

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