The European Union's pharmaceutical legislation has an important addendum, the legislation on paediatric drugs. It requires all applicants submitting a marketing authorisation application for a new molecular entity to provide a paediatric investigation plan (PIP). This mandatory PIP will be evaluated by the paediatric committee of the EMEA. The objective of the new legislation is to develop "better medicines for children" within the EU. 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 will provide the latest information on various aspects of the new legislation and how it is affecting drug manufacturers.
This audio conference is presented by Ulrich Granzer of Granzer Regulatory Consulting. To learn more, visit www.fxconferences.com.
Showing posts with label marketing authorization. Show all posts
Showing posts with label marketing authorization. Show all posts
Friday, June 27, 2008
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