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Session 4: Anonymisation Beyond Redaction: Case Studies
Session Chair(s)
Jennifer Vande Weghe, PHD
Director, Clinical Transparency & Disclosure, Amgen Inc., United States
Different methods and approaches are available to anonymise clinical data. Earlier in 2017 the EMA created a Technical Anonymisation Group (TAG). The aims and objectives of the EMA TAG will be presented. Under EMA POL-0070 many companies have initially used redaction to anonymise clinical data, but this method can reduce the utility of the data. Industry sponsors will share case studies of how they have been able to anonymise clinical data using other approaches and highlight key challenges and lessons learnt.
Speaker(s)
Janice Branson, MSC
VP Head of Statistics, Immunology & Dermatology Unit, Novartis Pharma AG, Switzerland
Implementation of EMA Policy 0070
Joergen Mangor Iversen
Principal Programmer, Biostatistics, LEO Pharma A/S, Denmark
Patient Level Data De-Identification at LEO Pharma
Vesela Kusheva
Clinical Disclosure Specialist, LEO Pharma A/S, Denmark
Patient Level Data De-Identification at LEO Pharma
Monica Dias, PHARMD, PHD, MPHARM, RPH
Head of Supply and Availability of Medicines and Devices, a.i., European Medicines Agency, Netherlands
EMA Technical Anonymisation Group (TAG) – Mandate and Composition
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