The orphan drug regulation in Europe came into force over 10 years ago, with the aim of stimulating research and development of medicinal products for rare diseases. Obtaining and maintaining orphan status opens up a number of opportunities to companies developing such products, but it is crucial to have a thorough understanding of the orphan rules in Europe in order to fully benefit from the incentives offered.

This audio conference presentation provides an overview of the legislative framework, and highlights the incentives available. Our speaker focuses on the most important aspects that need to be considered when compiling an application for orphan designation, and how this may impact the development program. Finally, the presentation summarizes both the potential pros and cons will be summarized.

This audio conference covers:

• The European legislative framework for Orphan Medicinal Products
• Criteria for orphan designation within Europe
• Incentives available for an Orphan Medicinal Product
• Important focus points within the application for an Orphan Medicinal Product and impact on development and marketing strategy
• Pros and cons of obtaining Orphan status within Europe

About the speaker:

Dr. Maureen Graham has over 25 years’ experience within the pharmaceutical industry and has worked for several different companies including Glaxo, Merck & Co, IVAX and Amgen. Dr. Graham has held a number of Directorships including European Director of Regulatory Affairs at Amgen. Dr. Graham founded Diamond BioPharm Limited in 2005, which is a leading technical and scientific consulting group of companies serving the biotechnology and pharmaceutical industry. Dr. Graham has direct experience with many types of products including biotechnology, gene-therapy, new chemical entities and generics. Dr. Graham also has a wealth of experience and expertise when it comes to the regulatory and product development issues associated with medicinal product for rare indications. Dr. Graham's experience covers products at all stages o! f development ranging from preclinical to registration.

Who should attend?

• Chief Medical Officers
• Chief Scientific Officers
• Regulatory Affairs Managers
• Business Development Managers
• Research and Development Directors
• Legal Counsel
• Senior Management