Chris Englerth

Recent Posts

Common Promotional Submissions in eCTD Errors and How to Avoid Them

November, 2019

Recently, the FDA held a free webinar in its CDER Small Business and Industry Assistance (SBIA) Webinar Series on “OPDP ...

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Highlights from the 2019 US TMF World Forum

November, 2019

In early October, Phlexglobal was honored to welcome industry TMF professionals from over thirty pharmaceutical ...

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Health Canada revises validation rules for eCTD format

May, 2019

As part of our continuous global regulatory updates and in case it did not catch your attention, please be reminded on ...

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How New EU Regulations Will Impact Regulation of Medical Devices

May, 2019

The adoption of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic ...

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FDA at DIA RSIDM 2019 – Presentations Highlights

February, 2019

As part of the DIA RSIDM conference in Bethesda, ML in February 2019, the following comprehensive list summarizes our ...

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Phlexglobal’s View on eCTD v4.0

October, 2018

eCTD has been around for nearly 20 years and we’ve seen how it has transformed the regulatory submission landscape. The ...

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Health informatics – IDMP – Implementation guidelines for ISO 11238

August, 2018

While the EMA is currently busy moving to the Netherlands and while the IDMP project currently seems to go slow, there ...

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