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Jul 02, 2014

EMA Adopts Changes to Trials Transparency Policy, October 2014 Start Date Predicted
The Clinical Trials Transparency finally signed!

The European Medicines Agency's (EMA) management board has signed off on the regulator's clinical trials transparency policy, adopting several changes along the way the regulator said would make the data the policy is intended to provide access to "more user-friendly."
The plan is being finalized and should be adopted by the EMA Management Board in July 2014. It is expected it will become effective as of 1 October 2014.
The plan also allows not only EU citizens to access existing clinical trial documents but – as in the past – will also enable competitors or generic companies to access large parts of EMA documentation submitted as part of a marketing application. Also for this reason the EMA is being criticized because its trial data publication plans may drive away drug R&D. Others, however, argue the agency is backtracking in a way that will hinder public health research.

More details online

Drug makers seek out-of-court settlement in clinical trial cases
According to the Indian drug regulator's website, merely 25 clinical trials have been approved by the DCGI in the first five months of 2014

In order to keep pace with the government's healthcare agenda, the pharmaceutical sector wants research work to go on, at any cost. In a letter to health minister Harsh Vardhan, the Indian Pharmaceutical Alliance (IPA), an industry body representing leading pharma companies, including Sun Pharma, Lupin, Dr Reddy's Labs, Cadila Health and Glenmark, stressed the need for an out-of-court settlement with health activists fighting for the rights of clinical trial participants. The letter says that the ongoing litigation in the Supreme Court is hindering drug development and research work in the country.

More details online

Years' worth of adverse event data made public by FDA
Open FDA project releases millions of reports

More than 3 million reports on medication errors and adverse drug events done since 2004 have been made public as part of the open FDA project. The FDA is hoping that the move will trigger new research and applications. Software developers now can develop tools that highlight and publicize safety information.

More details online

Most recent FDA directories
CBER & CDER key staff

The FDA updates regularly their directories of contacts. Here are the most recent lists.

CBER Key Staff Directory
CBER Contacts
CDER Key Officials
CDER Offices and Divisions

Big Data in Healthcare
A workshop organized by the Swiss Academies of Arts and Sciences

On July 1 in a one day workshop representatives from hospitals, general practitioners, insurance companies and academia discussed the impact of big data on Health Care: its challenges, opportunities and obstacles for implementation. Professor Donald Kossmann from the Institute of Information Systems at the Swiss Federal Institute of Technology presented an encryption solution overcoming the challenge of anonymization of personal health data. Beat Widler from Widler & Schiemann Ltd. review the significance of big data on clinical development and safety oversight activities.

More details online (only in German)
More details online


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