Technology Transfer  for the Pharmaceutical Industry

Course dates:	19 & 20 May 2010
	10 & 11 November 2010
Venue:	Window Conference Venue, Islington London UK
Cost:	£1160  + VAT £203.00 (Total £1363.00) A discounted rate of £1044.00 + £182.70 VAT (Total £1226.70) is available if booked and paid by Friday 12 March 2010

This 2-day interactive workshop is intended to provide an overview of the challenges that must be overcome in transferring technology and to highlight some proven techniques for overcoming those challenges.

Some of the benefits to be derived from this workshop include:

• An appreciation of where TT fits in the life cycle of a pharmaceutical product
• An appreciation of the importance of planning and product transfer
• An overview of the potential complexity of technology and product transfer
• An outline of proven best practice in technology transfer
• An opportunity to discuss current issues and challenges in technology transfer with peers and with an expert faculty

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

Speaker:

Chris Barnett, Director CMBarnett Pharma Services Ltd