Category Archives: Country News

This category includes any information that are specifically concerning one country.

US FDA Previews Future Direction of Electronic Submissions Programs

Jared Lantzy, Manager Global Regulatory Agencies and Processes at LORENZ Life Sciences Group, compiled a short summary of current and future technology initiatives at FDA presented at the 2016 DIA RSIDM.

Brad Wintermute, the Deputy CIO and Director of the Office of Technology and Delivery at FDA, opened the 2016 DIA Regulatory Submissions, Information, and Document Management Forum (DIA RSIDM) on Monday, February 8, 2016 by outlining current and future technology initiatives at the agency. It is very refreshing to see agency leadership not only paying attention to electronic submissions programs but identifying these programs as priorities essential to FDA’s mission.
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eSubmissions in Australia

Kent  BriggsThe presentation “eSubmissions in Australia” was given by Kent Briggs, Lead Senior Consultant at LORENZ Life Sciences Group, at LORENZ userBridge.14 in Milan, Italy.

In September, I presented the status of eSubmissions in Australia on behalf of the TGA. Since then, the TGA has been busy ensuring a quick and successful implementation of eCTD and setting the foundation for electronic review across all formats.

From the beginning, the TGA “pilot” was kept open allowing anyone to take part that expressed interest. As a result, the first eCTD applications began arriving in October and the first lifecycle sequences in the early parts of 2015.

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