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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

Novo Nordisk Pharmatech A/S enters a distribution agreement with Signet Chemical Corporation Pvt. Ltd. for cGMP Quaternary Ammonium Compounds for pharmaceutical and medical device applications

Novo Nordisk Pharmatech A/S has entered into an agreement with Signet Chemical Corporation Pvt. Ltd. for the distribution of their pharmaceutical range of quaternary ammonium compounds (FEF® Quats) to the healthcare industry in India, Bangladesh and Sri Lanka.
More info >>

White Papers

Nanoparticle Tracking Analysis. A Review of Applications and Usage in the Analysis of Exosomes and Microvesicles

NanoSight

The study of exosomes and other cell-derived microvesicles is an area of rapidly growing importance and the subject of intense interest and research. The previous lack of suitable methods for their detection, analysis, enumeration and phenotyping is proving to be a significant limitation in these studies. This mini-review shows the degree to which the technique of Nanoparticle Tracking Analysis (NTA) is helping to address these problems.
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Industry Events

SMi’s 9th Annual Biosimilars & Biobetters Conference

25-27 September 2018, Copthorne Tara Hotel, London, UK

Following the success of our previous events in both London and the US, Biosimilars and Biobetters UK 2018, SMi deliver a stellar speaker line-up and bring together a global audience of biosimilar experts to discuss the latest developments and future of the rapidly evolving and expanding biosimilars market.
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