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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

Source BioScience invest in digital pathology platform to enhance the outsourced histopathology service solution provided to the NHS and private healthcare

As a leading provider of outsourced histopathology services to the NHS and private healthcare centres in the UK Source BioScience has, after a detailed review of all other available alternatives in the digital marketplace, unveiled investment in a digital pathology platform from their preferred partner, Philips.
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White Papers

The Process of Informed Consent (written by ACRP)

CenterWatch

Every investigator and clinical research coordinator (CRC) should recognize the importance of obtaining valid and appropriate informed consent as an important protection of the rights and welfare of human subjects. The purpose of this ACRP guidance document is not to provide a literature review or summarize the recommendations of various working groups. Instead, the Association decided it would be helpful to provide short and focused guidance which describes how to best structure the informed consent process in accordance with best practices.
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Industry Events

RDD Asia 2018

14-15 November 2018, Grand Hyatt Kochi, Kerala, India

A must-attend meeting for pulmonary and nasal researchers, inhaled product developers and vendors active in this important pharmaceutical niche.
More info >>

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