The European Union’s paediatric regulation, which came into force two years ago, requires all applicants submitting a marketing authorization application for a new molecular entity to also provide a paediatric investigation plan (PIP). The objective of the new legislation is to develop "better medicines for children" within the EU. This mandatory PIP is being evaluated by the Paediatric Committee of the EMEA. There are obvious consequences for the pharmaceutical industry, as the PIP must be made available during submission, and paediatric trials will have to be performed.
In this audio conference we provide the latest information on various aspects of the legislation and how it is affecting drug manufacturers, including real-life experiences to date and lessons learned from those who have been through the process.
The EU Paediatric Rule: Threats, Issues & Lessons Learned is being presented by Dr. Ulrich Granzer, Owner, Granzer Regulatory Consulting and airs on Thursday, September 10, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com
