is being presented by Dr. Andrew Marr, Managing Director, of Marr Consultancy Limited and airs on Tuesday, Novemeber 1st, 2011. For more details, or to register please visit our site at www.fxconferences.com
The European Medicines Agency (EMA) recently announced that Marketing Authorisation Holders will have to provide medicinal product information for all authorised products in the European Union by July 2, 2012. This means an additional 400,000 records will need to be added to the Eudravigilance Medicinal Product Dictionary in less than 12 months, and information for 100,000 previously submitted products will need to be updated to meet new data and document requirements. This massive undertaking will impact every company with a medicinal product registered in the EU.
EMA has issued a detailed guidance and technical specification for providing this information – both data and product information (labeling) documents. These requirements pose a major challenge for industry to provide quality data on time. This audio conference presentation reviews the information EMA needs – and why – and discusses business process and technical options available to Marketing Authorization Holders, to support provision of data as required to EMA.
