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PUBLICATIONS

European Pharmaceutical Contractor

epc
Winter 2011
   
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Marketplace & Business

Editorís 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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Published quarterly in
February, May,
August, and November

News and Press Releases

Clinical and Regulatory Operational Excellence Forum

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment? Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
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White Papers

The Importance of ADCC in Assessing Clinically Relevant Differences

Sartorius Stedim BioOutsource Ltd

Biosimilars have caused a revolution in the development of biologic drugs. The model for biosimilars is a combination of speed to market and low cost; these are fundamental to any biosimilar development project. The biosimilars pathway to approval is not always without difficulty, biosimilars are still relatively new, and as each new applicant is reviewed we are learning more and more about these molecules.
More info >>

Industry Events

SMi Presents the 13th Annual Conference: Parallel Trade 2019

5-6 February 2019, Holiday Inn Kensington Forum, London

SMi presents its 13th annual Parallel Trade conference, taking place in London on the 5th-6th of February 2019. As the only parallel trade conference in Europe, this event provides the perfect platform for industry experts from both sides of the coin to come together and share perspectives on the practice of parallel trade.
More info >>

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