TOPRA welcomes the publication of the proposed regulation on paediatrics. This action is the culmination of a great deal of collaborative effort by the Commission, the EMEA, Industry, and TOPRA members as part of the consultation process.
This represents a significant change for the pharmaceutical industry in Europe. There will be important new requirements to make appropriate consideration of paediatric uses for drugs being developed. Understanding the obligations for firms regarding the Paediatric Investigations Plan and the separate marketing authorisation are essential for today’s regulatory affairs professionals. Recent research by TOPRA shows knowledge of these aspects is low with only around 20% saying that they are aware of the impact on marketing authorisations.
This publication gives a firm foundation and basis for the forthcoming TOPRA meeting on Paediatrics to be held in Brussels on 16 January, 2007.
Responding to the publication of the regulations, TOPRA Executive Director, Lynda Wight said, ‘We are very pleased with the publication of these regulations. We believe that this change will lead to better, safer outcomes for children across the EU and beyond. We are pleased to be able to complement the work at an EU-level with timely and appropriate educational opportunities for regulatory affairs professionals.
Building on previous work, TOPRA will hold a meeting in January in Brussels to continue its work on this important subject. This meeting will include input from those who drafted the legislation, those who will implement it from the regulatory agencies and industry and valuable insights from patient groups and paediatric physicians. This will assist participants in gaining a deeper understanding of the implications for them and their companies.’
For more information on the 16 January meeting or to book your place, please contact Christopher Bailey at email@example.com or by phoning the TOPRA office on +44 (0)1285 770 774.
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