Senior Manager Global Scientific Affairs
Renaud Janssen, Ph.D. is the Senior Manager of Global Scientific Affairs at Datwyler Pharma Packaging. He frequently presents on international conferences on subjects related to elastomeric and aluminium/plastic closures for pharm..
PROCESS WEIGHING AND RECORDING BY OBSERVATION This is the process flow for weighing the reference standard where the values are recorded by observation from the balance screen and written into a laboratory notebook by an analyst The subsequent calculations are performed using a handheld calculator with the results also written directly into the analysts laboratory notebook The volumetric flask i..
Abstract Introduction The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials RCTs however in some cases regulatory applications lack RCT evidence Objective To investigate the number and type of these approvals over the past years by the European Medicines Agency EMA and the US Food and Drug Administration FDA Methods Drug approval data were downloaded from the EMA website and the DrugsFDA database for all..
Abstract Background Slow and cumbersome laboratory diagnostics for Mycobacterium tuberculosis complex MTBC risk delayed treatment and poor patient outcomes Wholegenome sequencing WGS could potentially provide a rapid and comprehensive diagnostic solution In this prospective study we compare realtime WGS with routine ..
Qualitative and highresolution images premiered at the Berkley Lab as the fruit of the labour invested by the Department of Energys researchers there They succeeded in captivating ..
The target market for conducting global clinical trials has changed significantly, moving beyond ph..
Solasia Pharma KK Solasia Pharma formerly JapanBridge Inc is a pharmaceutical company that provides patient access to Western oncology therapies The company develops and commercializes oncol..
SWOT is both the most powerful and least understood strategic management tool Used correctly it translates the outputs of many other market analyses into a small number of key issues..
Gene family members of the ion channel and solute transporter SLC families represent both historical targets of pharmaceutical significance and serve as exciting opportunities for current and future therapeutic development The common property of ion movement for many of the SLCs lends itself to considering platforms used in ion channel research to enable early drug discovery In addition the convergence of advances in both genetic analysis and assay technology bodes well for the identification of the next generation of ion channel and transporterbased drugs in the near future..
Issues like approval delays deficiencies of functioning of CROs and other stake holders liabilities and compensation to injured subjects insurance issues etc still remain in India which has made multinational companies to rethink on opting for India to conduct clinical trials in India recently There is a need for a law to ensure that the people who undergo clinical trials are not exploited and should be well informed about risk as well to provide..
Most firms in the pharmaceutical industry think globally to expand demand for their products There are amenities from which firms leverage to launch a strategy to gain global market share These amenities include the regulatory dimension which helps reassign resources within and outside the firm..
The article presents a novel approach to applying Quality by Design QbD principles to the development of analytical methods Common critical parameters in HPLC gradient time temperature pH of the aqueous eluent and stationary phase are evaluated within the Quality by Design framework It is useful for the robust analytical method development and Design Space optimisation..
Cloud solutions offer immediate returns in improving operational performance and reducing costs Multiple approaches to cloud solutions will be needed to satisfy life science industry needs complicating the development of a coherent cloud strategy..