Regulatory Affairs for Biotech 2011

The process of drug development is changing rapidly as biotech techniques are becoming more mainstream, and more and more biotech based drugs are coming to market. Regulation of biotech products is fundamentally different from that of NCEs.

Are you fully aware of the extent of these differences and are you confident you have the knowledge you need to work in this field?

This course addresses the issues of real and perceived risks associated with biotech products, and the way the regulatory agencies are dealing with this based on the trainers own experiences. This course assumes some knowledge of the science behind biotech.

The Regultory Affairs for Biotech" course tacks real and perceived risks associated with biotech products, and the consequent interpretations of biotech regulations from a case study-centred approach. Demonstrating the critical steps to compliance. Leran if data generated is adequate for your dossier submission and this course will clarifying the manufacturing process for biotech products.

Who should attend?

• Regulatory Affairs
• Registration
• Compliance
• QA/QC
• Manufacturing/Production
• Product Validation
• Process Validation