Pharmacovigilance Strategies Workshop

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

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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

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

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

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Pharmacovigilance Strategies Workshop

Session 5: Data Science And Standards: Impact on Pharmacovigilance

Session Chair(s)

Bianca Mulder, PharmD, MPharm, MSc

James Whitehead, MBA, MSc

Speaker(s)

Challenges of Signal Management for Vaccine and the Various Data Solutions

Panel Discussion with Q&A, with additional participation:

Be informed and stay engaged.