spacer
home > epc > Autumn 2012
PUBLICATIONS

European Pharmaceutical Contractor

epc
Autumn 2012

   
Text
PDF
bullet
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.
 
view
download pdf
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.
 
view
download pdf
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.
 
view
download pdf
bullet
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.
 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf
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.
 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf
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.
 
view
download pdf
bullet
Reviews & Previews
Event Preview

Counting Down

Get ready to network and learn at the ICSE event in Feria de Madrid, taking place in October.
 
view
download pdf
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.
 
view
download pdf
bullet
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.
 
view
download pdf
bullet
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.


 
view
download pdf
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.
 
view
download pdf
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.
 
view
download pdf

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.
 
view
download pdf
   
spacer



Published quarterly in
February, May,
August and November

News and Press Releases

rfxcel Covers the Cost of EMVO Onboarding Fees

May 23, 2018 - San Ramon, CA – rfxcel Corporation, a technically certified Gateway Provider for the European Medicines Verification Organisation (EMVO) announced today that it will pay the cost of statutory fees payable to EMVO* for all manufacturers (Marketing Authorisation Holders, MAHs) which select rfxcel as their Gateway Provider before June 15th 2018.
More info >>

White Papers

Exploring Protein Stability by nanoDSF

NanoTemper Technologies GmbH

nanoDSF determines thermal and chemical protein stability with ultra-high resolution and with unmatched reproducibility. The detection of the intrinsic tryptophan and tyrosin fluorescence enables measurements at close-to-native conditions in any buffer, even in the presence of detergents. nanoDSF is applied in antibody engineering, membrane protein research, formulation and quality control.
More info >>

Industry Events

PREP 2018: 31st International Symposium and Exhibit on Preparative and Process Chromatography

8-11 July 2018, Hyatt Regency in the Baltimore Inner Harbor, MD, USA

The PREP series of symposia is the most recognized international conference devoted to advances in separation technologies in the field of preparative and process chromatography. Join us for a dynamic and innovative program where experts from around the world will address the latest developments and hottest topics in preparative and process chromatography.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement