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European Pharmaceutical Contractor

epc
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

York Health Economics Consortium offers a new health utilities training course

Cost-utility analysis is a requirement for NICE health technology appraisals and is being increasingly used in other contexts and countries. Health utilities, a crucial component of cost-utility analysis, capture the relative change in health-related quality of life resulting from a treatment. As such, health utility can be a key driver of the cost-effectiveness ratio. Obtaining health utility values that are suitable for your economic evaluation, however, may not always be straight forward.
More info >>

White Papers

Bio/Pharmaceutical Methods: Do your Analytical Methods Hold Up to Regulatory Scrutiny?

Eurofins BioPharma Product Testing

As FDA guidelines evolve and drug products on the market begin to age, bio/pharmaceutical manufacturers face scrutiny of the original methods used to support these products. Therefore, manufacturers must re-evaluate these methods to ensure they comply with current FDA expectations. Some manufacturers are even facing consent decrees imposed by the agency requiring them to bring methods up to current standards within a specified timeframe. This exercise requires significant amounts of time and resources, which many manufacturers do not have since they are focused on getting their next products to market. For that reason, some clients have been turning to Eurofins Lancaster Laboratories for support.
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Industry Events

BIO-Europe Spring 2018

12-14 March 2018, RAI Amsterdam, Europaplein, NL 1078 GZ, Amsterdam

BIO-Europe Spring® is the springtime counterpart to EBD Group’s flagship conference, BIO-Europe®, and continues the tradition of providing life science companies with high caliber partnering opportunities. Featuring EBD Group’s sophisticated, web-based partnering system, partneringONE®, the event enables delegates to efficiently identify, meet and get partnerships started with companies across the life science value chain, from large biotech and pharma companies to financiers and innovative startups.
More info >>

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