PharmaTraining, Window Conference Centre, Islington, London
19 & 20 May 2010
Day 1
Why Transfer Technology? • Pharmaceutical Product Life Cycle o Development o Innovative o Mature o Generic • Product Transfers and Technology Transfers o IP o Technology o Techniques Regulatory Considerations • Registration Procedures o Europe o Non-European • Variation Procedures o Types of Variations o Advantages and Disadvantages Day 2 Technical Challenges • Manufacturing processes • Validation • Stability • Packaging processes Logistical Challenges • Label Changes o Text o Physical • Timing o Project Plan o Phase in/out Human Challenges • Push versus Pull • Team membership and team roles • Cross-Cultural Issues • Progress Reporting and breaking bad news
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