Active since 2014, PHUSE’s Data Transparency Working Group provides subject matter expertise for the review of draft deliverables and guidance documents from regulatory bodies (such as the EMA and Health Canada), as well as other industry organisations (such as TransCelerate), and academia. Since their inception in 2020, the free-to-attend Data Transparency Events have gone from strength-to-strength. These virtual events have created an unrestrictive space where questions can be asked and challenges addressed. Individuals passionate about the area can come together to share vital knowledge, develop new ideas and spark innovation through presentations, panel discussions and Q&A sessions, alongside experts in the data sharing field.

The PHUSE Data Transparency Winter Event will take place from 6–8 February 2024. Data Transparency Events offer you the chance to gain knowledge and experience from a wide data transparency community, allowing you to come together with expects from a variety of companies and backgrounds.

During this virtual event, presentations will be delivered across the three days in bitesize chunks from 15:00-17:30 (GMT). There will also be a panel discussion and Q&A session focused on the day's themes. Registration will open 4 January!

Abby McDonell, Privacy Analytics

Abby McDonell is a Senior Program and Project Manager at Privacy Analytics. Abby manages anonymisation program activities for pharmaceutical clients by providing assistance in meeting regulatory deadlines and promoting transparency of clinical trial data. Abby is a member of the PHUSE Data Transparency Work Group and is a co-lead of the Good Transparency Practice project. She holds a BSc in Health Science and an MSc in Neuroscience.

Aga Glowinska, AstraZeneca

Aga Glowinska is the Director in Clinical Trial Transparency, Anonymisation for AstraZeneca. Aga received her PhD in Medicinal Chemistry at Warsaw University and is post-graduate in Statistical Analysis and Data Mining in Business. Aga has been with AstraZeneca for 5 years. Prior to her time in AstraZeneca Aga was a Statistical Programmer and Clinical Monitoring Associate. Today, Aga is focused on clinical documents anonymisation required for regulatory submission and Vivli requests. As part of her role Aga is actively involved in E2E standardisation of data collection & display within cross-functional initiatives.

Diwakar Angra, GENINVO

Diwakar Angra has 2 years of Experience in clinical data transparency process. He handles anonymisation of clinical datasets, documents and calculation of risk assessment. He has worked on various projects which are published on Health Canada and EMA. Diwakar is currently working with GENINVO as Anonymisation Analyst.

Lauren Hepburn, Rare Disease Sponsor

Lauren Hepburn is a Senior Clinical Trial Transparency Manager at a Rare Disease Sponsor. Lauren prepares clinical trial documents for submissions related to the European Clinical Trials Regulation (EU CTR), EMA Clinical Data Publication (Policy 0070), and Health Canada Public Release of Clinical Information (PRCI). Lauren is a member of the PHUSE Data Transparency Working Group and is currently co-leading the Good Transparency Practice project. She obtained her MSc in Biology and her BSc in Ecology and Evolutionary Biology.

Magdalena Majewska, AstraZeneca

Magdalena Majewska is the Senior Analyst in Clinical Trial Transparency, Clinical Document Anonymisation for AstraZeneca. She is responsible for leading multiple clinical documents anonymisation projects required for regulatory submission: under EMA Policy 0070 and Health Canada PRCI, but also for the requests falling outside these policies: EMA Policy 0043, FOIA. 

Magdalena has a strong interest in the holistic view of patient privacy protection.

Magdalena holds a Master’s degree in Medical Analytics from Medical University of Gdansk, Poland. Before joining AZ in August, 2021, worked for the Polish Competent Authorities, the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, where she was responsible for surveillance and vigilance of medical devices and in vitro diagnostic medical devices.

Obaraboye Olude, Privacy Analytics

Obaraboye Olude MBBS, MPH is a Clinical Trial Transparency Manager at Privacy Analytics. She has over a decade of experience in clinical trials data analysis. She has a background in Medicine and Public Health and has led several anonymisation and redaction projects for both regulatory and non-regulatory submissions.

Shalini Dwivedi, Krystelis

Shalini has 17 years of pharma industry experience, and for the last 8 years she has focused on the Clinical Transparency domain. Shalini has led the delivery of Clinical Data Transparency (CDT) projects to global pharma clients from trial registry support to redaction and anonymisation of documents as per EMA Policy 0070, Health Canada PRCI and EU-CDTR. Shalini has extensive knowledge of all relevant CDT regulations and frequently provides regulatory consulting advice to customers on CDT requirements. She is active in the CDT community globally, participating in industry forums and writing publications.

Zixin Nie, RTI International

Zixin Nie is a data privacy specialist within the Center for Data Modernisation Solutions at RTI International. He has over 7 years of experience working in data privacy. His current work at RTI involves designing systems to de-identify data and enable privacy-preserving record linkage for the National Heart, Lung, and Blood Institute’s Biodata Catalyst platform, evaluating de-identification requirements for the National Institute of Health’s Helping End Addiction Long-term Initiative, and developing models using synthetic data from RTI’s Synthpop. He is also leading a project for America’s Datahub Consortium to perform an environmental scan on Privacy Preserving Technologies.

Prior to working at RTI, Zixin worked at Privacy Analytics (a subsidiary of IQVIA), where he developed customised data privacy solutions for clients within government, industry, and academia within the United States and Europe, and helped to develop techniques and methodologies for re-identification risk measurement and tools for de-identification/anonymisation of data. He has also worked at Statistics Canada as a key member within the Confidentiality group within the Household Surveys Methodology Division, where he developed the statistical disclosure control rules implemented within the Generalised Tabulation System, a tool for automated calculation of aggregate statistics for dissemination to the Canadian public. The rules he created, along with the Generalised Tabulation System, have been widely used within Statistics Canada, covering 90% of published social survey statistics and the Canadian census.

Zixin is experienced in data de-identification and anonymisation, privacy impact evaluation, privacy by design principles, and has performed expert determinations under the Health Insurance Portability and Accountability Act.