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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

Phenomenex Introduces bioZen Series for Characterization of Biotherapeutics

Torrance, Calif. (April 16, 2018) – Phenomenex Inc., a global leader in the research and manufacture of advanced technologies for the separation sciences, introduces bioZen – a new series of LC solutions for bioseparations in pharmaceutical, biopharmaceutical and academic research. The series encompasses both proven and entirely new media spanning two particle platforms – core-shell and thermally modified fully porous – along with new biocompatible titanium hardware. The initial bioZen product line features seven chemistries for the UHPLC and HPLC characterization of biotherapeutics such as monoclonal antibodies, antibody-drug conjugates and biosimilars. The offering includes specific LC chemistries for the analysis of aggregates and total mAb, intact mass and fragments, peptide mapping and quantitation and glycan mapping.
More info >>

White Papers

Successfully managing the unique demands of cell therapy supply chains

PCI Pharma Services

Cell therapy professionals joined a specialist webinar by industry experts from PCI Clinical Services and TrakCel, addressing the unique complexity of an autologous therapy supply chain. Hosted by European Pharmaceutical Manufacturer magazine, the webinar was delivered by Rachel Griffiths, Associate Director, Technical Services, PCI Clinincal Services, and Dr. Matthew Lakelin, Vice President, Scientific Affairs and Business Development, TrakCel . Here, we present the white paper from that webinar event.
More info >>

Industry Events

SMi presents the 13th Conference on ADMET

9-10 July 2018, Holiday Inn Kensington Forum, London, UK

SMi is delighted to announce the 13th annual ADMET conference returning to London to explore the optimisation of ADMET modelling techniques, preclinical DMPK applications and development of biopharmaceuticals.
More info >>

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