Monthly Archives: August 2019

Two Prominent Topics on the userBridge.19 Agenda

This year’s userBridge conference in Athens, Greece is already sold out!

As a registered participant, you can look forward to a wide range of regulatory affairs perspectives from agencies, industry and prominent consultants.

Established under the overall theme “Learn, Discuss and Interact”, the conference covers a wide variety of presentations and tutorials focusing on practical solutions for current challenges regulatory and IT professionals face.  Find here two interesting abstracts which you can find on this year’s agenda.

For the final LORENZ userBridge 2019 agenda please click here.

Update on eCTD for China

In summer 2017, China was approved as the eighth regulatory member of the ICH. Since then, China’s regulatory landscape has undergone a transition of incredible scope and speed. A draft specification was published in March 2019, and we expect the launch of eCTD in December.

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Updates on the HMA eSubmission Roadmap

The eSubmission Roadmap v2.2 has recently been updated by the HMA. The purpose of the roadmap is to provide a high level strategic plan for business and technology changes over several years, and is meant to help NCAs, EMA and pharmaceutical industry prepare themselves for the forthcoming changes. Many of the adjustments are likely due to the EMA’s relocation.

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