Regulatory updates March 2006

Europe
Press releases
- European medicines agency (emea) adopts the first positive opinion for a similar biological medicinal product
- Emea finalizes set of guidelines on similar biological medicines and publishes two new concept papers
- Good manufacturing inspection guidance update

USA
- cber compliance program guidance manual: inspection of biological drug products-cpg7345-848

Slide presentations
- WCBP 2006: 10th Anniversary Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products
- Cell Product Reporting Workshop
- CMC Strategy Forum: Standard Reference Materials for Biopharmaceutical Products: Strategies to Support Product

Meetings
- Vaccine Production: Potential Engineering Approaches to a Pandemic
- FDA Science Forum, A Century of FDA Science: Pioneering the Future of Public Health

For more information please download the document on Regulatory updates web page