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

Share Article

Xtalks presents a live webinar on September 11, 2012 at 10:00am EDT on pediatric drug development. Register for the webinar at

News Image

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.

For more information or to register go to

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit

Karen Lim (416) 977-6555 ext 227

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Client Services
(416) 977-6555 227
Email >
Visit website