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Volume 16 Issue 1
 
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Paediatric Regulations are Permanent: Approaches for Overcoming the Challenges of Paediatric Drug Development

Global regulators have, for many years, put in place provisions and regulations to ensure that children’s specific medical needs are addressed through structured clin...
25 September 2012 Uncategorized
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Good Distribution Practices – Why and to What Detail GDP-contracts between Sponsors/Manufacturers and Distributors are Needed

A revision of the European GDP-guideline has been published for public consultation on December 31, 2011. Although defining the requirements for the wholesale distrib...
25 September 2012 Uncategorized
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FDA Expands Rules on the Disqualification of Clinical Investigators

In April 2012, the US Food and Drug Administration announced in the Federal Register the publication of a final rule to amend the investigational new drug application...
25 September 2012 Uncategorized
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Global Commercial Drug Supply for Trials: How to Achieve Long-term Success
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Global Commercial Drug Supply for Trials: How to Achieve Long-term Success

In the past, the majority of companies were rather naive regarding their options for sourcing comparator medications. Some companies, even large ones, were relying on...
31 July 2012 Uncategorized
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London 2012: Potential Logistical Challenges

Unless you have been living under a rock for the last four years, you can’t have failed to have noticed that the 2012 Olympics are taking place in London this summer!...
13 June 2012 Uncategorized
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Journal For Clinical Studies has a distinguished editorial advisory board providing the best guidelines for global clinical trials. Your resource for Multisite Studies and emerging markets.

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