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New legal requirements for conducting clinical trials in Italy
A decree goes into effect March 14th requiring minimum insurance for any company conducting clinical trials in Italy. The new requirements were established by Italy’s Ministry of Labor, Health and...
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Pending changes to insurance standards for Russian clinical trials
Effective 9/1/10, there are changes to the Federal Drug Law pending in Russia that will have a material effect on the approval and management of clinical trials that are being conducted there. The...
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Costs and larger trials among the factors driving the globalization of...
Although significant drug and medical device R&D activity remains within the United States, representing close to 50% of total worldwide expenditures over the last 10-15 years, a clear trend toward...
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Stricter standards for India’s clinical drug trials
Following allegations against pharmaceutical multinational companies (MNC’s) for using humans as guinea pigs to conduct illegal clinical trials, India’s Supreme Court has ordered that all clinical drug...
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FDA officials warn drug makers: comply or face sanctions
Having already faced serious legal threats from regulatory agencies last year, India’s pharmaceutical industry is now under additional scrutiny from the U.S. Food and Drug Administration officials are...
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New insurance template for Swiss clinical trials
The Swiss Ethics Committees on research involving humans has recently released a new certificate of insurance/policy template that insurers must follow. As part of this new format, the Committee now...
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France issues stricter rules for pharma trials
The French government took measures last week to lower the health risks to clinical trial participants following the final report regarding a phase 1 clinical trial that killed one person and...
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