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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

BioIVT Acquires Optivia Biotechnology, Adding Transporter Assay Products and Services to its ADME-Tox Portfolio

BioIVT, a leading provider of research models and services for drug development, today announced that it has acquired Santa Clara, CA-based Optivia Biotechnology and its comprehensive portfolio of transporter assays, multi-transporter models, transporter systems biology, and molecular transport research solutions.
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White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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Industry Events

Pharmaceutical Packaging and Device Labelling Europe

11-12 September 2018, Munich, Germany

Relaunching the event after a three year hiatus, Pharma Packaging and Labelling Europe is back to deliver key, actionable insight on the very latest regulatory requirements, technological innovations, strategic developments, and how to implement them into your packaging and labelling chain with both maximum efficiency and minimal cost. The conference is packed with thought provoking innovative discussions.
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