Issue No # 15  July 15th, 2009

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Introduction: FDA Releases a Draft Guidance on Injection Devices
Dr Michael Gross
Biologics Consulting Group, Inc
Advanced processes, controls & inspection innovations for prefilled syringes
Dr Andrea Sardella
Stevanato Group SPA
Focusing on the expertise in prefilled syringe components
Stelmi SA
The advantages & challenges of developing a drug product in prefilled syringes
Dr Gerald Hofer
Fresenius Kabi Product Partnering
Company Profile
The Importance of Extractables & Leachables Testing for Injectable Drug Delivery Systems
Fran L DeGrazio
West Pharmaceutical Services
Equipping a complete syringe line, from filling to palletisation
Mr Pietro Tomasi
Mr Massimo Pannini
Marchesini Group SpA