In addition to the fundamental elements PHUSE are renowned for delivering, for 2021 we are excited to welcome advanced educational sessions to the US Connect agenda.

The live week will centre around six key content pillars. Each of these themes will host presentations, a Hands-on Workshop and a panel discussion – the agenda is jam-packed with interactive content! Don’t miss out on this opportunity to sharpen your knowledge of pivotal areas within the industry: register your place now at the US Connect 2021.

COVID-19

At the EU Connect 2020, attendees heard about COVID-19’s impact on clinical trials. This year, find out what companies did to cope during the pandemic.

Take a deep dive into how companies have managed programming deliverables under Emergency Use Authorisation (EUA) and their strategies and lessons learnt during what has been a challenging year. How did our industry peers react to shortened timelines and increased pressure, and still deliver high-quality results to get desperately needed vaccines to the world?

Emerging Trends

Explore emerging trends within life sciences that impact clinical data analysis.

You will hear from industry experts on the technical challenges with implementation of metadata repositories; you can get your hands dirty with an interactive introduction to R workshop; and you can listen to presentations exploring how knowledge graphs can improve a clinical reporting workflow.

Leadership

The art of innovative leadership is the ability to inspire and adopt the new without eroding the benefits realised by the old. To be a leader is to motivate a group of people to act towards achieving a common goal, demonstrating core soft skills such as communication, integrity and empathy.

On the Thursday of the Live Week, attendees can immerse themselves in topics such as building knowledge capacity for a high-performance team and agile transformation in clinical research.

Regulatory & Submissions

Regulation within healthcare ensures the protection of the public from unsafe providers, through enforcement of professional practice and standards. Here to discuss regulatory and submissions are experts from across the industry, including a key presenter from the FDA.

We will be looking at FDA and PMDA submission data requirements, FDA conformance analysis and, of course, pandemic-disrupted studies. Focus will be on challenges companies have faced implementing CDISC and FDA COVID-19 guidelines for NDA submission.

Data Science

Data science describes a cross-functional field which uses scientific methods to extract knowledge from data. The pharma and healthcare sector has been using data science methods for more than 50 years to provide data-driven evidence.

The importance of data science is clear, but have you wondered what story your data is telling you? Are you wondering about the science behind making the data useful? Take your first step in growing from programmer to data scientist through the Data Science agenda.

Our very own Education Director, Sascha Ahrweiler (Bayer), will be hosting a Data Storytelling Hands-on Workshop. The PHUSE Education platform has a dedicated cluster for Data Science – find out more via the link.

Future of Clinical Trial Reporting

What does the future of clinical trial reporting look like? Learn more about the challenges of embracing new technologies in the world of good clinical practice. Hear live from RStudio on transitioning to R, and from TransCelerate on their MoA framework for assessing accuracy, reproducibility and traceability.

There will be an interactive Hands-on Workshop on the PHUSE SCE White Paper, which addresses establishing “a set of recommendations for the standard set of requirements of a modern analytics platform”.