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Industry Events

9th Annual Outsourcing in Clinical Trials Europe 2019

14-15 May 2019, Milan, Italy

Now in its 9th year, the Outsourcing in Clinical Trials Europe event is firmly established as the leading platform for the biopharmaceutical industry to collaborate to improve clinical trial partnerships, accelerate development timelines and leverage new technologies. Over 500 clinical professionals from biopharmaceutical and solution-provider companies attended the 2018 conference in Barcelona to develop new partnerships and find answers to their most pressing clinical trial challenges.
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White Papers

Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market. Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
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News and Press Releases

Biotechpharma to Expand Process Development and GMP Manufacturing Capacity to 5,000L

Biotechpharma UAB, a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced further expansion of its fermentation capacity to 5,000L along with an additional state of the art process development laboratory, investing more than 50 million in the expansion.
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