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European Pharmaceutical Contractor

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Autumn 2017

   
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Clinical Trials
Examining Operational Efficiencies
Top Tips for Clinical Quality

Manufacturing and clinical practices, while seemingly at opposite ends of the industry, are quite similar in their overarching aim, states MasterControl’s Patricia Santos-Serrao.
 
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Legal & Regulatory
ICH GCP Revision 2
Compliance and Modernisation

With the recent revision to the ICH GCP E6 Addendum, organisations in the EU are tightening their practices to meet the new requirements, explains Dr Laura Brown at Laura Brown Training and Development.
 
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Clinical Research
Placebo-Controlled Designs
Ethical Approaches

KCR’s Dr Piotr Piotrowski, Dr Magdalena Czarnecka and Dr Anna Baran debate the ethics behind placebo use in clinical trials, acknowledging the advantages of additional risk mitigation solutions.
 
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LABS & Logistics
Site Training
Qualified Matters

Marquard Lett and Gordon Elger at UL Compliance to Performance suggest that proper managerial systems could eliminate staff training and certification issues in trials.
 
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Interview
Q&A: Barcode Labelling
Clear Lines
Loftware’s Laura Johnson
sits down with EPC to discuss barcode labelling challenges and benefits, including integration of the method into Good Clinical Practice standards.
 
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Published quarterly in
February, May,
August and November

News and Press Releases

PCI Pharma Services Announces Acquisition of Millmount Healthcare

Philadelphia, PA – October 2, 2017 – Leading pharmaceutical outsourcing services provider PCI Pharma Services (PCI) has announced the acquisition of pharmaceutical and healthcare contract packaging services provider Millmount Healthcare, located near Dublin, Ireland.
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White Papers

pAVEway™ expression system for the efficient expression of therapeutic proteins

Fujifilm Diosynth Biotechnologies

One of the major bottlenecks in the production of biopharmaceuticals is the efficient expression of therapeutic proteins in microbial or mammalian cells. The Escherichia coli pAVEway™ expression system described here has been developed to ensure high product titres and efficient scale up to GMP manufacture, whilst minimising many common issues seen in other expression systems, such as ‘leaky’ expression (expression of recombinant protein in the absence of inducer).
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Industry Events

CPhI India 2017

27-30 November 2017, Bombay Exhibition Centre & MMRDA Grounds, BKC

Connect, network and interact with 1,400+ exhibitors at India's largest and leading pharmaceutical event. CPhI and P-MEC India is the gateway for you to meet the movers and shakers in India’s pharma industry to source high quality pharma solutions at the most competitive prices. Register today for free via: gotocphi.com/india2017
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