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European Pharmaceutical Contractor

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Winter 2011
   
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Marketplace & Business

Editor’s Letter

Dr Graham Hughes considers the increasing world population and its effect on the industry.

 
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Pharmaceuticals and the Environment

Strategies for Sustainability

As organisations come under increasing pressure to improve their green credentials, David Taylor at wca Environment considers how waste can be reduced throughout the pharma sector.

 
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R&D Growth

Survival of the Simplest

As pharmaceutical companies expand, they become increasingly complex organisations to change. Melvin Jay and Simon Collinson of the Simplicity Partnership suggest that companies should be aware of the problems that can arise as a result of unnecessary complexity in their structure.

 
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UK: R&D Sustainability

Reshaping Big Pharma

R&D has been hit hard by the global recession. Jonathan Trethowan of TRAC Services analyses the steps taken by large pharmaceutical companies to overcome these obstacles to productivity.

 
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Clinical Trials

Clinical Trial Management

Rules of Engagement

Michael Hantzperg of ICTA Systems explains how interim analysis allows for valuable reassessment points throughout a clinical trial.

 
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Legal & Regulatory

Medical Imaging: FDA Guidance

Image Conscious

Paul A van Meurs and Colin G Miller at BioClinica Inc analyse the FDA guidance on the use of medical imaging for endpoints in clinical trials, and suggest that a charter should be integral to image interpretation.

 
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Clinical Research

Real-World Studies

Gathering the Evidence

Krista Payne, Sallyanne Williams and Jess Sohal at United BioSource Corporation suggest that planning evidence generation at the start of the research process is the best approach to take.

 
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e-Data

Electronic Health Records

Setting the Standard

Jeffrey Cohen and Joshua Pines at Medidata Solutions explore steps that have been taken to integrate clinical technologies with electronic health records management.

 
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Electronic Trial Master Files

Digital Solutions

Karen Redding at Phlexglobal Ltd assesses the transfer from paper to electronic trial master files and highlights the advantages and risks of this technology.

 
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Biomarkers & Drug Development

Logistics: Biomarkers

The Right Path

Despite the advances in biomarker technology, are biomarkers being used to their full potential? Russ Hager at BioStorage Technologies suggests that improved cold chain management and facilities will help encourage their application.

 
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Drug Discovery: Biomarkers

Making your Mark

Biomarker discovery and development is a complex process which requires a comprehensive study design to ensure that the right information is obtained, as Bob Holt at Tepnel Pharma Services, Gen-Probe discusses.

 
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Therapeutics

Respiratory & Ocular Drug Development

Up to the Challenge

Anne Marie Salapatek, Victoria Nelson, Natasha Camuso and Fiona Soong at Cetero Research weigh up the most effective ways of testing the efficacy of respiratory and ocular treatments.

 
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Clinical Laboratories & Logistics

Clinical Supply Chain

Stretched to the Limit

Petra Bielmeier at F Hoffman La-Roche Ltd, and Geert Crauwels and Jim Williams at Lodestone MC discuss how best to overcome the pressures facing the clinical supply chain.

 
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Data Management & IT Solutions

Data Management: Cloud Computing

Up in the Clouds

Subhro Mallik at Infosys explores the benefits of cloud computing for the pharmaceutical industry and how adopting the right model can allow for the secure storage of important data.

 
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IT: Cloud Computing

Pharma Forecasting

The benefits of transferring to a cloud computing system have been discussed widely in recent years. However, as Thierry Grenot at Ipanema Technologies explains, this IT solution also has a number of disadvantages which must be appreciated.

 

 
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Central Labs

Central Laboratories

Drug Development Enters a New Era

The role of central laboratories is changing. Arnold Verbeek at Clinical Reference Laboratory Inc comments on how central labs have responded to globalisation and the trend towards personalised medicine.

 
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Manufacturing Environment

Packaging: Green Approaches

Perfecting Packaging

Intelligent and well-designed packaging and logistics services are playing their part to improve the sustainability of pharmaceutical companies, as Karen Adams and Roland Nicholas at SCA Cool Logistics discuss.

 
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Cool Chain, Labs & Logistics

Global Clinical Supply Chain

Fragile Goods

Globalisation of clinical trials and the growing number of temperature-sensitive materials calls for tighter management of the supply chain, as Alex Klim of DHL Supply Chain explores.

 
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August and November

News and Press Releases

Novo Nordisk Pharmatech A/S enters a distribution agreement with Signet Chemical Corporation Pvt. Ltd. for cGMP Quaternary Ammonium Compounds for pharmaceutical and medical device applications

Novo Nordisk Pharmatech A/S has entered into an agreement with Signet Chemical Corporation Pvt. Ltd. for the distribution of their pharmaceutical range of quaternary ammonium compounds (FEF® Quats) to the healthcare industry in India, Bangladesh and Sri Lanka.
More info >>

White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
More info >>

Industry Events

Pharmaceutical Packaging and Device Labelling Europe

11-12 September 2018, Munich, Germany

Relaunching the event after a three year hiatus, Pharma Packaging and Labelling Europe is back to deliver key, actionable insight on the very latest regulatory requirements, technological innovations, strategic developments, and how to implement them into your packaging and labelling chain with both maximum efficiency and minimal cost. The conference is packed with thought provoking innovative discussions.
More info >>

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