Pharmacovigilance Audits and Inspections Summit – November 7, 2018

Shelley Gandhi has been invited to present a session at the Pharmacovigilance Audits and Inspections Summit – November 7, 2018 • Wyndham Philadelphia Historic District • Philadelphia, PA

Her session will cover:
Examine Evolving Global Pharmacovigilance Regulations and the Impact on Audit and Inspection Readiness

As regulations are changing domestically and around the globe, it is important to keep
up to date on the many different regulatory issues (including data integrity regulations)
that affect your audits and inspections. During this session, learn more about current
and pending regulatory developments that affect PV audits and inspections.


Align Global Data Collection and Analysis Systems • Ensure Cross -Functional Collaboration and Preparedness • Achieve Accurate and Timely Reporting

  • The volume of audits and inspections is growing rapidly
  • Audits and inspections currently consume an inordinate amount of PV’s time and attention
  • Global PV regulations are incredibly detailed
  • Managing, reviewing and sharing an increasing amount of data is tremendously complex
  • Cross-functional cooperation and seamless collaboration with 3rd parties is critical


  • Understand areas of regulatory focus related to PV audits and inspections
  • Create internal processes and best practices for managing audits and inspections
  • Benchmark with colleagues — Consider ways to work in partnership with regulatory affairs, quality, medical affairs, clinical development and manufacturing
  • Examine ways to efficiently and effectively capture, manage and report on data
  • Consider the future state of PV audits and inspections

Click here to find out more.