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Session 5: Data Science And Standards: Impact on Pharmacovigilance
Session Chair(s)
Bianca Mulder, PharmD, MPharm, MSc
Pharmacovigilance Assessor
Medicines Evaluation Board, Netherlands
James Whitehead, MBA, MSc
Former Senior Director Device & Digital Safety - AstraZeneca
Visiting Lecturer - Pharmacovigilance MSc Course, University of Hertfordshire, United Kingdom
Every day, massive amounts of data are generated from myriad sources that could potentially be harnessed to support the regulation and oversight of medicines. As a result, “big data” analysis is becoming more and more relevant every day, especially during the COVID pandemic. This session will give an insight into innovative regulatory and industry initiatives on big data and various data solutions
Speaker(s)
Challenges of Signal Management for Vaccine and the Various Data Solutions
Isobel Anderson
Astrazeneca, United Kingdom
Panel Discussion with Q&A, with additional participation:
Bianca Mulder, PharmD, MPharm, MSc
Medicines Evaluation Board, Netherlands
Pharmacovigilance Assessor