European Pharmaceutical Contractor |
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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 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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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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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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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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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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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
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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