Registering Biological And Biopharmaceuctical Products In Europe

The regulatory procedures in the European Community for biological and biotechnological medicinal products are complex and in a period of transition. A proper understanding of these procedures; of the technical issues affecting quality, safety and efficacy of biologicals; the appropriate use of Expert Reports; and an awareness of developments within the ICH process are all essential if an efficient regulatory strategy is to be developed by both the pharmaceutical manufacturers and the regulatory authorities. Additionally, there are specific areas to be considered for classical biologicals such as vaccines and blood products and the emerging biotechnology products. This forum will provide practical guidance on registering biologicals and biopharmaceutical products in Europe, covering quality, pre-clinical and clinical aspects.