November 2020

1 - EudraCT Results Modalities Posting Updated

A new version on Results: Modalities and Timing of Posting was published on 28 Sept 2020

2 - PHUSE EU Connect 2020 - Workshop: "Calculating the Risk of Reidentification of Patients"

Cathal Gallagher's workshop at PHUSE EU Connect 2020 "Calculating the Risk of Reidentification of Patients in Excel, Foundations for Document Anonymisation" was held on November 13th.

Cathal led a series of exercises to anonymise data sets in Microsoft Excel. The workshop illustrated the differences between qualitative risk assessment versus quantitative risk assessment. You can download the Workshop documents on the PHUSE Resource page

Cathal will also be hosting the following 'On-Demand Sessions':

• Software Demo: "Risk Driven Data & Document Anonymisation"
• "Achieving Balance - Approaching Anonymisation with Quantified Risk"

View the PHUSE Resource page for more details on the presentations d-wise is leading, workshop documents, and how to get post-event coverage if you aren't attending this year.

A summary of the above workshop is presented here.

3 - FDA COVID-19 Transparency Commitment

On 17 Nov 2020, FDA reaffirmed its commitment to transparency around the Emergency Use Authorization (EUA) for drugs and biological products, including vaccines, as part of its COVID 19 response. EUA for vaccines is explained on this page.

FDA is attempting to promote transparency and public confidence in the agency’s scientific review process and the appropriate use of such COVID-19 products authorized for emergency use by posting the scientific reviews for EUAs issued, revised, or revoked for drug and biological products on the FDA website.

Further, on 20 Nov 2020, FDA announced an Advisory Committee to discuss the Pfizer-BioNTech vaccine candidate.

4 - EMA implements additional transparency for COVID-19 trials

On 30 Oct 2020, the EMA implemented two further transparency measures for COVID-19 medicines, by publishing both the clinical data in support of the authorisation of Veklury (remdesivir) per Policy 0070 guidance - and information on the COVID-19 treatments and vaccines that have received scientific advice or informal guidance from EMA’s pandemic Task Force (COVID-ETF).