EMA Features eSignature Workshops - Applied Clinical Trials


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EMA Features eSignature Workshops

Source: Applied Clinical Trials Digital Edition

The European Medicines Agency (EMA) has announced it is hosting a series of ‘webminars’ to assist users of its eSignature solution. The sessions start at 11 am and last up to 60 minutes, and will take place on January 22, February 5 and 19, and March 5.

The EMA has introduced capabilities to produce digitally signed electronic documents and to verify incoming digitally signed electronic documents from the areas of Scientific Advice, Orphan Medicines and Pediatric Medicines in portable document format (PDF). It provides specific PDF-certified electronic application forms that enable the pharmaceutical industry to digitally sign and submit using a PDF reader application. These capabilities are part of the strategy to increase electronic document-only exchanges with the pharmaceutical industry and regulatory bodies.

Industry will benefit by being able to exchange digitally signed documents, based upon specific acceptability criteria, according to EMA. The exchange of digitally signed electronic documents could bring cost savings to industry by removing the need to print documentation and incur courier charges. Electronic document exchanges also may increase efficiency and eliminate the requirement for archiving paper documents.

For further details about the webminars click here.


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As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
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