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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

Horizon Discovery and Fulcrum Therapeutics Form Collaboration for Novel CRISPR-Based Target Discovery in Genetic Diseases

The collaboration will utilize Horizon’s world-leading CRISPR-based screening platform to identify novel targets for regulating gene expression.
More info >>

White Papers

The Impact of Components on Drug Quality and Risk Mitigation

West Pharmaceutical Services, Inc.

Expectations for quality by regulatory agencies are increasing at a very fast pace, especially for prefilled drug delivery formats, thanks to increased focus on reducing risk to patient safety. The trend has resulted in delays for new drug applications, more recalls of marketed products and even drug shortages if the container system and drug contents are suspect for quality issues. The pharmaceutical market is now requiring manufacturers of containers and components to meet new expectations with a quality culture and very high product reliability. The need to bridge the gap and provide superior quality products has been a driver for manufacturing technology investments, more robust control strategies and the introduction of next generation elastomer components.
More info >>

Industry Events

LogiMed 2017

18-19 October 2017, Hyperion Hotel, Hamburg

Taking place 18-19th October in Hamburg, LogiMed is Europe’s only dedicated medical device supply chain event bringing together over 150 Medical Device Supply Chain Professionals to network with. With a greater focus on customer collaboration and digital transformation this year’s LogiMed delivers real insights on inventory visibility, supply chain planning, global logistics and digitalization.
More info >>

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