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European Pharmaceutical Contractor

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Summer 2014

   
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Marketplace & Business
CRO Marketplace

Value Added

Adam M Dion
at GlobalData suggests that accomodating a diverse range of clients is the best solution to challenges facing contract research organisations - companies are now offering new services to increase revenue and appeal to firms which are set to lead future innovation.

 
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Process Management Systems

Business Growth


Improving process management is always worthwhile, whatever a company’s goals. Richard Holland at TBM Consulting says renewing your system could be the key to greater efficiency, long-term reliability and continuous productivity.
 
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Legal & Regulatory
Clinical Trial Regulation

All Change


Recent updates to EU clinical trial regulation will impact many areas of drug development, says ICON's Daphne Smyth. Among the benefits of the changes are quicker access to treatments and streamlined legislation across member states.

 
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Drug Approval

The Right Path


With the ever-present need for greater efficiency and lower costs, Ken Phelps at Camargo Pharmaceutical Services explains why some companies are turning to the 505(b)(2) pathway, which opens up a quicker, less expensive drug development route.

 
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Intellectual Property

Added Protection


A good understanding of intellectual property protection can deliver increased revenue and the ability to tap into market niches. However, applying initiatives is a complex task, argue Victor Caddy and Lyndsey Lynch at Wynne-Jones IP.

 
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Outsourcing Regulatory Affairs

Safe Strategy

MakroCare’s Mahesh Malneedi
describes the best strategy to implement when choosing to outsource regulatory affairs. He recommends devising a risk-averse plan and selecting a firm with varied offerings.
 
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EU Pharmacovigilance

A New Mindset


The full impact of the pharmacovigilance updates of 2012 is yet to be seen, believes Doris Stenver at the Danish Health and Medicines Authority. She suggests that the revisions will eventually lead to a whole new way of thinking.
 
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Therapeutic Innovation
Vaccine Formulations

New Potential


The new development of solid state circular dichroism goes beyond traditional vaccine analysis. Allan Watkinson and Jan Vos of XstalBio explain how this technique can offer a deeper understanding of formulations.
 
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DATA MANAGEMENT
Serialisation Programs

Bigger Data


Ramesh J Chougule of Infosys explains how implementing a new serialisation program – and moving away from traditional data tracking methods – can translate into improved efficiency, precision and cost-saving.
 
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STAFF RECRUITMENT & TRAINING
Competence Verification

Standard of Care

Martin Robinson
at the International Academy of Clinical Research outlines the findings from a recent report highlighting the need to readdress patient requirements and increase the public's protection. He reasons that competence verification could remedy the issues.


 
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Clinical Laboratories
Microbiological Testing

The Central Issue


Deciding on the most suitable type of laboratory for the microbiological stage of a clinical trial can be problematic. PSI CRO's Andrey Karelin, Maxim Belotserkovsky, Veronika Khokhlova and Olga Sazonova outline the various considerations

 
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Cool Chain, Labs & Logistics
Cold Chain

Evolving Markets


Stephen Healy at Intelsius demonstrates why emerging markets possess the greatest opportunity for market growth, and how they could contribute to a supply chain evolution.
 
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Interview
Industry Interview

Better, Faster, Stronger


Helping customers accelerate research progress is the most rewarding part of Jim Carroll’s role at iCTRS. Here, he tells EPC how to get ahead when reducing patient enrolment timelines.
 
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Industry Interview

Data Driven


Elizabeth Brooks at Decision Driver Analytics speaks to EPC on why business decisions should be approached with a rigourous and practical view, while being driven by analytics.
 
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Published quarterly in
February, May,
August and November

News and Press Releases

Horizon Discovery Licenses Biomanufacturing Cell Lines to Centre for Process Innovation (CPI) and National Institute for Bioprocessing Research and Training (NIBRT)


More info >>

White Papers

Medpace Reference Laboratories establishes state of the art Flow Cytometry techniques for flexible approaches to clinical trials across multiple therapeutic areas.

Medpace

Cytometry is the process of measuring the properties of individual cells. These properties may include gene or protein expression, chemical properties, deoxyribonucleic acid (DNA) content, and various cellular functions. The earliest methods of cytometry relied upon light microscopy for the classification and observation of cells and cellular components. Microscopy permitted direct visual observation of cells for the first time, leading to the classification of cells by morphology and insight into cellular functions. However, the time required for microscopic analysis constrains the number of samples or number of cells in each sample that can be examined. Therefore, the utility of microscopy for analysis of rare cells or in situations where sample throughput is a priority is limited. Flow cytometry was developed largely to improve upon these limitations.
More info >>

Industry Events

Pharmaceutical Microbiology East Coast

13-14 November 2017, Renaissance Woodbridge Hotel, New Jersey

Drawing on from the huge success of SMi’s Pharmaceutical Microbiology event series, SMi is delighted to announce the launch of Pharmaceutical Microbiology East Coast. Being the eighth in its series, this event will take place in New Jersey, USA, on November 13th and 14th 2017. Aimed at Microbiologists, Quality Control and Quality Assurance Managers, Pharmaceutical Microbiology East Coast 2017 will address the best practices for rapid microbial and sterility testing and tackle the challenges of contamination control.
More info >>

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