Having listened to our supporter companies’ interest in returning to in-person events, PHUSE is delighted to confirm its commitment to the US Connect 2022 being held in person on 1–4 May in Atlanta, Georgia.

Companies are updating their domestic travel/conference guidance, and policy implementation is expected to take a few more weeks. Based on this data, the Early Bird discount will remain available until 25 February 2022.

The PHUSE ticket allows full access to the event in Atlanta, with flexibility to switch to remote access at any time leading up to the event (selected sessions excluded).

Take a look at the FAQ page, which will address the vaccine requirements, pre-testing and masking for the event.

Sponsorship opportunities are selling fast, with availability remaining for the Connect Café, Passport to Learn and exhibition. Take a look at the prospectus and support the work of a PHUSE Connect.

The EU Connect 2022 will take place at the ICC in Belfast, UK, 13–16 November.

We can't wait to welcome our EU attendees back in person this year, with the core focus of facilitating meaningful connections in our industry.

Register for February's Webinar Wednesday to hear Gary Kennedy, Connect Chair, talk about Call for Papers, the Connect Streams and the submission process.

The prospectus will be available soon, register your interest with events@phuse.global.

All materials from the EU Connect Engagement Hub have now been transferred to the PHUSE Archive for everyone to access. Browse your favourite presentations at any time, using the filters to narrow down your search.

Take a deep dive into the Leadership and Innovation content at the event through our recent blog written by Bhavesh Patkar, Parexel, Leadership & Innovation Best in Stream Winner.

Join us for the first Single Day Event of 2022. The India Spring SDE, which will be held virtually on Saturday 19 March, will feature six presentations exploring the theme of ‘Application of Open-source Technologies in Data Sciences and Analytics’.

Attendees will look at the usage of R programming, at Python and Julia languages for clinical trial data analysis, and explore more about potential opportunities in using open-source technology for regulatory data submissions.

Keep an eye on the PHUSE Events Calendar for further information on all 2022 SDE dates, which are due to be released soon.

The prospectus will be available shortly. If you are interested in sponsoring a Single Day Event, please contact the Events Team.

Our PHUSE virtual Data Transparency Winter Event is free to attend. Starting tomorrow and carrying on through until 10 February, the event will be held in bitesize chunks each afternoon from 15:00 to 17:30 (GMT).

Presentations will include updates from regulatory agencies (the EMA and Health Canada) and sessions on the EU Clinical Trial Regulations, Data Anonymisation and the Data Sharing Process. Each day will include a joint panel discussion and Q&A session.

400+ individuals are already registered. There's still time to secure your place and join the event!

Thank You to Our Sponsors! 

February's Webinar Wednesday is taking an exciting approach by featuring an introduction and walkthrough to the new PHUSE website features. Attendees can also look forward to delving into the PHUSE Archive with Anup Patel, PHUSE Technical Director. 

Hear from Gary Kennedy, Connect Chair, about the EU Connect 2022 Call for Papers opening. There will also be a presentation on the Implementation of Estimands Using Data Standards from Chris Price, PHUSE Working Groups Director.

We hope you will be able to join us on 23 February at 15:00 (GMT) 16:00 (CET) 10:00 (EST). 

Call for Volunteers!

Good Transparency Practices – Project Co-Lead and Members

The project aims to define a set of best practices for data transparency and create a Good Transparency Practice guidance. The best practices will help ensure anonymised data is compliant with the legal requirements, as defined by regulators, as well as preserving as much data utility as possible. 

Deliverable Out For Review

The PHUSE Bioresearch Monitoring Data Reviewer’s Guide (BIMO) project team have prepared a final draft version of the BIMO Data Reviewer’s Guide Package (BDRG).

The purpose of this is to allow upfront communications to the FDA regarding sponsor consideration, and deviations from the latest BIMO Technical Conformance Guide (TCG). In an effort to avoid the Information Requests that are currently issued by the agency to sponsors, the guide will address inconsistencies between sponsors’ interpretation of the BIMO TCG and the format and content of the Bioresearch Monitoring Data Reviewer’s Guide.

The team is respectfully calling for public feedback on the package, which includes a BDRG template, completion guidelines and examples. Before reviewing these documents, please read through the BDRG introduction and overview. 

Please submit any feedback to workinggroups@phuse.global by 15 February, using the review feedback tracker to log your comments.

• BDRG Template
• BDRG Completion Guidelines
• BDRG Example 1
• BDRG Example 2
• BDRG Example 3

Published Blog 

Safety Analytics have recently published a blog – Adverse Event Collection Recommendations Blog.

Here you can read about new opportunities for 2022, including vacancies spanning a wide array of levels and locations across the industry. Navigate through the job listings by using the search tool.

If you would like to post a job with us, kindly access the application form below. If you have any enquiries, please email communications@phuse.global.