1. Various other updates Presented by: Karen S Ginsbury March 2012 1

2. FDA Process Validation Guidance 2 Finalized January 2011 Companies manufacturing for US market should have implemented it by now – would at the very least be expected to have a policy in place for legacy products and to follow the guide for new products being launched

3. FDA Guidance on Contract Manufacturing 3 Promised in 2011 – not yet ready Top of list – confirmed at PDA / FDA in September Anticipated first half of 2012 Will talk about sponsor responsibility for oversight of outsourced operations

4. MHRA Compliance Program Status 4

5. BIMPs Quality Documentation Draft 5

6. Requirements are quite draconian E.g. Need comparability from phase 1 – phase 2 6

7. BIMP Quality Documentation Requirements prior to phase 1!!! 7

8. Are the requirements realistic Will patients be denied new therapies because companies cannot invest the resources at this stage of development What about risk to benefit for a critically ill patient Where are you industry representatives and why haven’t you commented!!! 8

9. Thank You for your attention Questions? Where to now? 9