Sandra Luciano of AMCOR observes that, although child-resistant packaging cannot be a substitute for other safety measures CR/SF packaging improves consumer trust of a pharmaceutical brand by helping to reduce the chance of a child gaining access to medications.
Max Horn of Vetter Pharma-Fertigung GmbH & Co. KG argues that for pharmaceutical and biotechnology manufacturers, PLM is critical, considering the enormity of the expense, time and effort it takes to bring a drug to fruition.
The aim of this article by Neil Jones of Patheon is to look at some of the challenges that need to be considered when outsourcing activities from early phase through to late phase development, then scale-up, and ultimately commercialisation.
Sally Grosvenor of Novozymes Biopharma identifies the reasons why the industry must address regulatory concerns in addition to process and product efficiencies, which have the potential to translate to cost reductions in the manufacturing process.
Michael Breul, the Director of Lufthansa Cargo’s Competence Center, explains about the heating and cooling shipping containers and how they help when transporting temperature-sensitive airfreight consignments, regardless of weather conditions and within predetermined temperature ranges.
The PMDA adopted the guideline in October 2009, and following an intervening ‘grace period’ it will become fully implemented on 1st November this year. Dr Rick Turner, Senior Scientific Director, Cardiac Safety Services at Quintiles, reviews this implementation.
Anthony S. Chilton, President and Chief Executive Officer of BASi, puts forward three key observations post the commercial impact of the economy in the CRO industry.
In addition to being more economically viable for companies, a critical advantage of this approach is that it offers greater consistency for clinical trials, while significantly increasing data quality – explains Amy Furlong, Executive Vice President, Cardiac Safety Operations of ERT.
Dr. Betsy Hughes Formella of Bioskin GmbH explains why the development and validation of appropriate methodologies to determine the rate and extent to which a topically applied drug reaches its site of action within the skin is one of the biggest challenges in dermatological research today.
Eric Halioua Etienne and Marc Sokal of Promethera Biosciences explain that cell therapy has been identified as the best alternative tool to overcome scarcity of organ donation.
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