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CCT Venues

Oct 12, 2022 2:00 PM - Oct 13, 2022 10:30 PM

Level 32, 40 Bank Street, London, E14 5NR, United Kingdom

Pharmacovigilance Strategies Workshop

Engage in the sharing of good practices between industry representatives and seek advice from regulators in this unique workshop

Session 5: Data Science And Standards: Impact on Pharmacovigilance

Session Chair(s)

Bianca  Mulder, PharmD, MPharm, MSc

Bianca Mulder, PharmD, MPharm, MSc

Pharmacovigilance Assessor

Medicines Evaluation Board, Netherlands

James  Whitehead, MBA, MSc

James Whitehead, MBA, MSc

Senior Director, Device & Digital Safety

AstraZeneca, 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


Isobel  Anderson

Challenges of Signal Management for Vaccine and the Various Data Solutions

Isobel Anderson

Astrazeneca, United Kingdom

Bianca  Mulder, PharmD, MPharm, MSc

Panel Discussion with Q&A, with additional participation:

Bianca Mulder, PharmD, MPharm, MSc

Medicines Evaluation Board, Netherlands

Pharmacovigilance Assessor

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