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European Pharmaceutical Contractor

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Winter 2017

   
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Clinical Trials
Enrolment Challenges

Global Goals

With elements ranging from clinical constraints to cultural and global regulations, coordinating a clinical trial can be challenging. Debbie Elliott, Colleen Grawe, Jaqueline Moore and Gina Steidle at Medpace examine the decisions involved.
 
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Designing First-in-Human Studies

Plotting the Route

Reaching that first-in-human trial is a significant step in all clinical research. Dr Torkel Gren at Recipharm Pharmaceutical Development and Anders Millerhovf at CTC Clinical Trial Consultants explore options for simplifying the process.
 
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Trial Design Precautions

Suggestions for Success


Nuala Ronan and Deborah Arthur at Databean take a look at how regulations and increased costs can be reduced for small businesses and start-ups developing medical devices.

 
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Published quarterly in
February, May,
August and November

News and Press Releases

Aptus Clinical enters into a global partnership agreement with Artelo Biosciences

We are delighted to announce that Aptus Clinical has entered into an agreement with Artelo Biosciences to provide clinical development support the re-purposing of its high-potency dual cannabinoid agonist ART27.13 in oncology.
More info >>

White Papers

Cleaning Validation: What do you need to consider to ensure a successful outcome?

RSSL

Cross contamination must be avoided in the Pharmaceutical industry at all costs and successful cleaning validation ensures that patients are not put at risk due to cross contamination. The process can be divided into a number of sections each of which must be fully understood and areas of concern addressed to ensure a successful outcome across the entire process. This spans both the manufacturing and subsequent analytical and microbological support. The data used to confirm a positive/successful cleaning validation is underpinned by the results of validated analytical methods. It is essential that these results are truly representative as patient safety is based upon the absence of equipment residues. So what are those areas of concern, what affects your ability to get a successful outcome and what do you need to consider when carrying out a Cleaning Validation exercise?
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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