Are you prepared for the new EU Medicines legislation?

The BIA is holding a one-day seminar, supported by its Regulatory Affairs Advisory Committee and sponsored by Arnold & Porter UK LLP, to enable bioscience companies to prepare for the new requirements and processes to be implemented by November 2005. As part of the implementation of the new EU pharmaceutical legislation, the EMEA is currently developing guidelines and procedures for the authorisation and supervision of medicinal products in collaboration with the European Commission and Member States. These new provisions provide tools to speed up patients? and healthcare professionals? access to medicinal products in the EU and introduce measures for better safety monitoring through a pharmacovigilance network. This has also led to the introduction of a regulatory pathway for the approval of biosimilar products in Europe. For more information please click "here":[ http://www.bioindustry.org/biodocuments/BIARAACNov05.pdf].

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