PhUSE Monthly News & Updates

May 2019

Dear PhUSE Member

Below you will find key information regarding PhUSE events and updates for May.

EU Connect 2019: Register Now

Registration is well underway for the EU Connect in Amsterdam. Register your place by 26th July to benefit from the Early Bird discount.

Call for Papers at a Record High!

Call for Papers closed on 26th April, with a record-breaking 298 abstracts submitted! The Connect Committee now have the tough task of selecting the best papers to bring you interesting topics from across the industry. Authors will be notified in June.

Connect Hotel

This year, we have secured rooms at the Ramada Apollo Amsterdam Centre. Book via the PhUSE website for the discounted rate.

US CSS 2019 Silver Spring

The CSS conference is fast approaching. We are pleased to confirm our seven FDA keynote speakers! Information on the discussion can be found here.

Registration for the workshops is now open! Four workshops have been added to the exciting CSS agenda. Click here for details or listen to the webinar held on 24th April featuring an update from the presenters.

To find out more about our sponsors for this year's CSS, please view our e-flyers here.

If you haven't yet booked your hotel, you have a few more days in which to benefit from the PhUSE discounted rate at the Marriott CourtyardBook before 3rd May. 


FDA Announcement: Public Meeting in Silver Spring

The FDA is holding a public workshop in Silver Spring on Wednesday June 12 2019, the day after the close of the CSS. See below for details:

Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities

When: Wednesday, June 12, 2019 | 9AM-4.30PM

Where: Tommy Douglas Conference Center, 10000 New Hampshire Avenue, Silver Spring, MD 20903

For further details incuding the agenda and how to register, please visit the Duke University website.

SDEs in May

Beijing, China, 17th May

"Interaction with Data – Regulatory Requirements and Automation Applications"

London, UK, 20th May

"Real-world Evidence"

Hyderabad, India, 18th May

"New Era of Biometrics in Clinical Development"


For the 2019 Single Day Event schedule, click here.


Working Groups News

Working Groups

The Demystifying Define-XML Codelist for Nonclinical Studies project has provided recommendations for specific problems/questions encountered, when fulfilling the Define-XML codelist section for nonclinical studies. To view the project's recommendations, visit the SEND Implementation Wiki page.

The PhUSE Optimizing the Use of Data Standards Working Group has published a White Paper on Best Practices for Documenting Dataset Metadata: Define-XML Versus Reviewer’s Guide. Click here to view the paper. 

The Cloud Adoption in Life Sciences Industry project has been updating the Framework document. Version four is now available to view and download here.


We are pleased to confirm that following the recent advertisement calling for a Working Group Co-Lead to support Emerging Trends and Technologies, Dhananjay Chhatre, or DJ, will officially take on this role effective from 1st May alongside Andy Richardson. We would like to thank those that took the time to submit their applications and wish DJ the very best of luck.


Effective from 30th April, our distribution list forum Listbox will no longer be active. The PhUSE Office is working on an alternative solution and will be in touch with relevant stakeholders in due course.

Webinar Wednesday 22 May 2019

The agenda for this month's Webinar Wednesday will focus on the forthcoming CSS in Silver Spring, in June. If you are unable to attend the webinar, be sure to catch up with the content ahead of the CSS.


If you're looking for a rewarding challenge in 2019, then consider volunteering for PhUSE. We have opportunities available within the Working Groups to help solve issues around health product development and regulatory review. We would also warmly welcome volunteers to share their knowledge and tips by contributing to the PhUSE News. By participating, our volunteers gain hands-on experience in an external environment that aims to broaden their horizons.

We have the following opportunities available:

Membership volunteers needed in the following regions: EMEA, Americas and APAC. Contact

Join a number of Working Groups projects. Contact

If you would like to volunteer but cannot see the activity listed here, please do not hesitate to get in touch. For more information, contact


Click on the above image for information on PhUSE advertising opportunities.

If you would like your advert to feature in the PhUSE Monthly News, please contact our Marketing & Communications team at