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.

This audio conference covers:

• Understanding of the long-term direction of EMA's informational needs
• Key elements of EMA's current mandate for provision of EVMPD data
• Challenges in the providing quality data on time
• Business process and technical options for support

About the speaker:

Dr. Andrew Marr is managing director with Marr Consultancy Limited, providing a specialty in regulatory operations. He has 27 years of leading-edge experience working within regulatory affairs/regulatory operations of a major pharmaceutical company plus leading roles in numerous industry/regulator collaborative projects, including as chairperson of ICH Expert Working Groups and of the PIM programme. Andrew is a recognised thought-leader on the creation, management and exchange of electronic information between industry and regulators.

Who should attend?

• Directors, Regulatory Affairs
• Directors, Regulatory Operations
• Directors, Pharmacovigilance
• Directors, Drug Safety
• Directors, IT/Regulatory Support