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European Pharmaceutical Contractor

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Autumn 2012

   
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Business and Finance
Emerging Markets: Economic Outlook

A Brave New World

Joe Nellis at Cranfield School of Management examines current changes in both developed and developing markets, and what these might mean for the future of the pharmaceutical industry.
 
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Strategic Alliances

Model Partner

James McSweeney at ICON Clinical Research considers how a ‘nimble’ approach, based on an effective partnership between CRO and sponsor, can improve R&D productivity and help companies differentiate themselves in a challenging marketplace.
 
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Personalised Medicine

Call to Action

In order to capitalise on developments in personalised medicine and encourage further innovation, governments will need to establish accessible reimbursement systems and payment pathways, as Susan Garfield of GfK Bridgehead International and Edward Abrahams of the Personalized Medicine Coalition explain.
 
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Clinical Trials
Clinical Trial Supplies

Missing Link

The growth in global clinical trials has forced Big Pharma to rethink temperature-sensitive packaging and its cool chain practices. David Johnson of Cool Logistics answers some of the questions surrounding the clinical trials supply chain.
 
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Legal & Regulatory
Medical Device Classification

What’s in a Name?

The regulatory line between a medical device and a medicine in the EU can be minute. Peter Bogaert and Sarah Cowlishaw at Covington & Burling LLP outline the legislation governing their classification, which can often cause uncertainty.
 
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Medical Device Combination Products

Device Advice

As the current regulations on drug/device combinations come under fire, Shayesteh Fürst-Ladani of SFL Regulatory Affairs and Scientific Communication Ltd speculates that global harmonisation could be the answer to this international issue.
 
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Biosimilars Development

Myth or Reality?

Rodeina Challand of PRA investigates the continued evolution of biosimilars and of the regulations which are governing their development in light of the demands of a growing biologics market.
 
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Drug Development & Delivery
Modelling and Simulation: PK/PD

Current Practice, Future Goals

Michael O’Kelly at Quintiles examines the rapid adoption of modelling and simulation of PK/PD processes, and suggests that this will soon be a necessity across the drug development landscape.
 
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Modelling and Simulation:CNS

Targeted Approach

Serge Bischoff at Rhenovia Pharma divulges the potential of modelling and simulation to improve the field of CNS drug discovery and development by bringing together multidisciplinary teams of researchers and generating knowledge pre-bench.
 
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Clinical Pharmacology Units

Early Clinical Networks

The rising costs facing biopharma mean that clinical pharmacology units must adapt in order to remain efficient and financially stable. Wolfgang Höffer of Clinical Research Services Andernach GmbH examines the recent market transition and the benefits offered by networked CPUs.
 
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Reviews & Previews
Event Preview

Counting Down

Get ready to network and learn at the ICSE event in Feria de Madrid, taking place in October.
 
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Industry Interview: Almac

Open Partnerships

Philip Diamond of Almac talks to EPC about the CRO industry, and what he is looking forward to at ICSE.
 
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Data Management & IT Solutions
ePRO: Mobile Technology

Dial M for Health

Mark Brincat and Hannah O’Gorman at Exco InTouch observe how mobile technology is contributing to the evolution of ePRO reporting, and why customised mHealth solutions are a step in the right direction.
 
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DATA MANAGEMENT
Adaptive Trial Designs

Dealing with Data


Davide Garrisi
and Kerry Dyson at CROMSOURCE investigate how new risk-based management models in clinical trial operations can support adaptive trials, patient safety and data reliability.


 
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Electronic Data Capture

Empowered Patients

Tools such as smart phones and tablets are enabling more patients to monitor and manage their disease. Elizabeth Hernberg-Ståhl at Late Phase Solutions and Jani Söderhäll at PC PAL outline how this affects patient engagement.
 
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Clinical Trials: eConsent

Electronic Relations

Susan Brink at ConsentSolutions explores the rising use of electronic tools for patient consenting and outlines the changes that must take place to clinical trials in order for this method to be effective.
 
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Medical Writing
Medical Writing

The Art of Communication

The language used in instruction leaflets can lead to low levels of comprehension, causing harm through incorrect dosage and compliance. Lisa Chamberlain James at Trilogy Writing and Consulting Ltd proposes potential solutions that could help to resolve this problem.
 
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Published quarterly in
February, May,
August and November

News and Press Releases

BioIVT Acquires Optivia Biotechnology, Adding Transporter Assay Products and Services to its ADME-Tox Portfolio

BioIVT, a leading provider of research models and services for drug development, today announced that it has acquired Santa Clara, CA-based Optivia Biotechnology and its comprehensive portfolio of transporter assays, multi-transporter models, transporter systems biology, and molecular transport research solutions.
More info >>

White Papers

Overcoming research challenges with Adaptive Trials

PCI Pharma Services

There has been cause for concern within the pharmaceutical industry over the last five years, regarding increasing research and development costs, combined with a fall in the number of new drugs brought to market. In an attempt to overcome this issue there has been a significant rise in the use of adaptive clinical trial designs, whilst saving time and money as well as facilitating more effective decision making. One of the biggest challenges that pharmaceutical companies have experienced has been delivering compliant clinical trials supplies across diverse patient populations in the relatively short timeframes that adaptive trial designs require, remaining focused on ensuring that patient compliance and product quality is in no way compromised. This demand has led to the launch of fast response services that support Research and Development in responding to changing dosing regimens mid-trial.
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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