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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 MasterControlís 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

KCRís 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
Loftwareís 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

Sphere Fluidics Closes a $4.8 million USD (£3.7 million) Funding Round

Cambridge, UK, 10 June 2019: Sphere Fluidics, a company commercializing single cell analysis systems underpinned by its patented picodroplet technology, announced today that it has closed an additional tranche of investment of $2.9 million (£2.2 million), securing a total of $4.8 million (£3.7 million) in investment. The funding will be used as working capital for the Companyís Cyto-Mineģ Single Cell Analysis System, expansion of the UK facility and enable the doubling of personnel through the opening of a new US Sales Office and Demo Lab in California.
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.
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Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
More info >>

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