Pharma Training, Window Conference Venue, London UK
9 & 10 May 2011
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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