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home > > Autumn 2017

PUBLICATIONS

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.

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.

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.

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.

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.

News and Press Releases

Aggreko’s Matt Watson Awarded Full Membership to the Institute of Refrigeration

A temporary solutions specialist has further consolidated its position within the refrigeration sector with a key team member joining an industry-leading organisation. Matt Watson, Aggreko’s Manufacturing & HVAC Sector Sales Manager for the UK and Ireland, has joined the Institute of Refrigeration (IoR) as a full member. His membership to the institute marks a recognition of his position as a responsible industry professional and the depth of his knowledge on cooling equipment solutions.
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White Papers

The Importance of Critical Temperatures in the Freeze Drying of Pharmaceutical Products

Biopharma Group

Every formulation has a critical temperature, below which it should be cooled for complete solidification and maintained below during primary drying in order to prevent processing defects. To design a freeze drying cycle on a rational basis such information should be identified.
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