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European Pharmaceutical Contractor

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Spring 2012
   
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Marketplace & Business

Contract Manufacturing: China

Making Progress

Maxine K Fritz and Scott Tatlock at Becker & Associates Consulting, Inc explore the benefits of outsourcing to CMOs in China, and consider the essential criteria for selecting a manufacturing partner.

 
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Big Pharma: 2012 Forecast

Beyond the Patent Cliff

Nick Beckett at CMS Cameron McKenna provides an in-depth review of developments within the pharmaceutical industry over the past year, and considers the changes that 2012 may bring.

 
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Sponsor-CRO Partnerships

Room for Improvement

A presentation at the 2011 Partnerships in Clinical Trials event given by Uwe Schneider of Grünenthal GmbH considered the lack of change within the pharmaceutical industry over the last 12 years. Uwe Schneider and Graham Hughes report on the findings of this presentation.
 
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In Conclusion

As Time Goes By...

Graham Hughes considers how the pharmaceutical industry has developed over the last 30 years.

 
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Clinical Trials

 Adaptive Trial Designs

Evolution or Revolution

Adaptive trial designs offer the potential to reduce clinical development costs. Judith Quinlan at Aptiv Solutions explores the benefi ts of this revolutionary methodology.

 
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Legal & Regulatory

Social Media: AE Reporting

Taking the Plunge

The pharmaceutical industry has been reluctant to embrace the benefi ts of social media. Elizabeth E Garrard of Drug Safety Alliance, Inc explains that increasing regulatory guidance will help the industry to overcome its fears and utilise platform for adverse event reporting.

 
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Paediatric and Geriatric Drug Development: FDA Regulations

Age Concerns

Pete Joiner and Ken Phelps at Madeira Therapeutics explain how new FDA regulations will help to increase research into paediatric and geriatric drug development.
 
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Medical Writing: Responses to Authority Questions

Finding the Answers

Julia Fornjanic Klapproth of Trilogy Writing and Consulting breaks down the process of responding to marketing approval questions.

 
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Clinical Trials Supplies

Clinical Trial Supply Sourcing

Strategic Alliances

The globalisation of clinical research means that finding the right clinical trial supply sourcer is more essential than ever. Lekishia White at Multipharma suggests that assessing a potential partner’s capabilities is an essential part of this process.

 
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Drug Discovery, Development & Delivery
Neurology: Sleep-Related Disorders

Counting Sheep

The lack of treatments for sleep-related disorders is set to be overturned with the development of biomarkers, electroencephalograms and spectral analysis, as Hubert Bland at Surrey Clinical Research Centre explains.
 
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Reviews & Previews

Book Review

A Comprehensive Account

Graham Hughes reviews Global Clinical Trials: Effective Implementation and Management, edited by Richard Chin and Menghis Bairu.

 
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A Time for Change?

Graham Hughes reviews the November 2011 Partnerships in Clinical Trials conference.

 
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Paediatrics Special Focus: Clinical Development and Regulatory Updates

Spotlight: Paediatric Research

Joined-up Thinking

Emma Sala Soriano and Irmgard Eichler at the European Network of Paediatric Research, EMA (Enpr-EMA), and Peter J Helms of the Scottish Medicines for Children Network at Child Health, University of Aberdeen, explore the initiatives of the Enpr-EMA in the field of paediatric medicine.

 
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Paediatric Drug Development

Youth Movement

EMA-approved paediatric investigation plans now force pharmaceutical companies to think about how their drugs will affect children. Klaus Rose at klausrose Consulting advises outsourcing to paediatric specialists in the face of this requirement.

 
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Data Management & IT Solutions
Data Transparency

Whose Data is it Anyway?

Gareth Adams and Melissa Nezos at PRA discuss the recent calls for increased data transparency, and look at the effects of electronic documentation on the availability and ownership of clinical trial data.
 
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Electronic Data Capture: Oncology Trials

Performance Enhancement

Successful integration of modern electronic data capture (EDC) technology can help streamline complex trials. Emma Banks at Datatrial considers the benefits of adopting EDC, and how to meet regulatory requirements.
 
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Electronic Documentation: SMEs

On the Record

As electronic documentation becomes an increasingly necessary component of clinical trials, Rolf Marugg and Georg Mathis at Appletree AG present the options available for the small- and medium-sized enterprises.
 
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Connected Health

Making the Connection

mHealth technology can offer greater trial flexibility, evidence-based results and increased patient adherence as Mark Evans of Adherence Science Ltd and Kavita Oberoi of Oberoi Consulting explain.

 
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LABS & Logistics
Logistics: Controlled Room Temperature Shipments

Specialist Solutions

Nathan Barnard at Biocair International considers the options for transporting temperaturesensitive products, and suggests that taking a risk management approach to selecting a logistics solution is essential.
 
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Regional Focus

Regional Focus: Indonesia

Partnership Potential

With a growing economy, vast patient pool and increasing number of clinical trial sites and specialists, Indonesia offers an attractive solution for global clinical trials, as Endang Hoyaranda of Prodia the CRO shows.

 
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Regional Focus: Ukraine

Ironing out the Creases

As the pharmaceutical market in Ukraine continues to grow, its position as a viable alternative to the west for conducting clinical trials has been strengthened by the development of anticorruption law, as Timur Bondaryev and Svitlana Postrygan of Arzinger explore.
 
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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

Advantages of Quantitative NMR for the Determination of Relative Response Factors

Novatia, LLC

Quantitative NMR (qNMR) is a technique that is being applied broadly and at an increasing rate in the field of pharmaceutical analysis (1). This white paper highlights the advantages of using qNMR to determine Relative Response Factors (RRFs) for pharmaceutical impurities detectable by HPLC. A single determination of RRFs using qNMR allows for simple and accurate quantitation of impurities which eliminates the need for preparation, qualification, and storage of reference standards. An example is presented here, which demonstrates quantitation of known impurities that have variable responses to UV-VIS detection, thereby providing a more accurate assessment of impurity levels than UV-VIS response alone.
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Industry Events

PDA Parenteral Packaging 2019

19-20 March 2019, Hilton Molino Stucky, Venice, Italy

PDA Europe’s Conference has become a must-attend event for all professionals in the Parenteral Packaging arena. Join us in Venice in March 2019 to continue and further deepen scientific advancements and our ongoing professional discourse of latest on primary packaging technologies and business trends. This conference and the accompanying exhibition address quality of components and cont­ainers, container closure development and integrity testing as well as aspects of processing, product distribution and storage.
More info >>

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