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home > epc > Autumn 2017

PUBLICATIONS

European Pharmaceutical Contractor

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.

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News and Press Releases

Datwyler celebrates official opening of its new production plant with First Line standard in Middletown, Del

• The new facility in Middletown, Del., is Datwyler’s third facility with First Line standard which will be catering to the markets in North and South America • Approximately 120 jobs will be created, with the majority staffed from the local community • With the Middletown facility, Datwyler will be able to increase its global First Line production by 50 percent by 2020 • First Line is specially designed to manufacture biotech and pharmaceutical elastomer components in a fully integrated good manufacturing practice (GMP) environment
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White Papers

High-tech Packaging for High-tech Medicine

West Pharmaceutical Services, Inc.

As more biologics and biosimilars come on to the global pharmaceutical market, they can and will present unique packaging and containment challenges. For materials that are sensitive to glass or that may require larger-dose volumes or custom configurations, cyclic olefin polymers may offer a solution. These novel materials for drug container closure systems can provide a needed alternative to traditional glass containment systems for advanced therapeutics.
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Industry Events

Drug Delivery Partnerships 2019

28-30 January 2019, PGA National Resort & Spa in Palm Beach Gardens, FL

For 23 years, DDP has been the world’s largest drug delivery meeting place to accelerate drugs to market and lengthen lifecycles for long term profitability by finding new partners, new drug delivery technologies, and new formulation development strategies. Year after year this event brings together top scientists and business development leaders from Biotech, Pharma, Generics, Specialty Pharma and Drug Delivery companies to share, discuss, and collaborate. If you work in drug delivery, commercialization/licensing, med device, formulation, biologics, biosimilars, and similar areas, you can’t miss this event!
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