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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, MSc

James Whitehead, MSc

  • Patient Safety Medical Device Lead
  • 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)

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

  • Pharmacovigilance Assessor
  • Medicines Evaluation Board, Netherlands

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