Brian Sanderson of Chiltern (Early Phase) argues that although new studies have their place, the more traditional Phase I studies have evolved over the years, with new thinking being applied along with a wealth of expertise available to add value.
Amy Furlong, Executive Vice President, Cardiac Safety Operations at ERT shows how centralising the process of collection and standardisation of quality ECG data, and employing digital ECG systems and a core laboratory, not only reduces inconsistencies that may occur from site to site, but in addition helps to alleviate laboratory and site workloads.
Current status of the transition from paper to electronic regulatory submissions in the European Union
This article by Martin T. Moxham of iRegulatory Ltd summarises the current situation regarding acceptance of electronic regulatory submissions in the European Union.
Non-Clinical Development of Pharmaceuticals: Consequences of the recent update of the General ICH M3 Guideline
Antoine Wellink of NOTOX addresses here the changes compared to the previous version, and the consequences for the design of a preclinical programme to support different phases of clinical development and marketing authorisation.
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.
Safe Products and Technologies for the Pharmaceutical Industry – Optimising your Manufacturing Process, Drug Formulation and Drug Delivery
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.