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PUBLICATIONS

European Pharmaceutical Contractor

epc
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

TLX Cargo and EMBALL ISO agree a partnership that allows pharmaceutical companies and airlines to have a single point of contact for the thermal protection of their shipments

St Georges de Reneins, January 28th 2019 _ TLX Cargo, part of TLX insulation Ltd, world leading manufacturer of thin reflective insulation for 25 years, offer its Thermal blankets through EMBALL’ISO worldwide commercial network.
More info >>

White Papers

Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market. Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
More info >>

Industry Events

Bio Europe Spring 2019

25-27 March 2019, Messe Wien Exhibition and Congress Center, Vienna

BIO-Europe Spring® is the springtime counterpart to EBD Group’s flagship conference, BIO-Europe®, and continues the tradition of providing life science companies with high caliber partnering opportunities. Featuring EBD Group’s sophisticated, web-based partnering system, partneringONE®, the event enables delegates to efficiently identify, meet and get partnerships started with companies across the life science value chain, from large biotech and pharma companies to financiers and innovative startups.
More info >>

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