The 2nd Pharmacovigilance Audit and Inspections Conference – The 2nd Pharmacovigilance Audit and Inspections Conference

Being adequately prepared for pharmacovigilance audit and inspections is crucial to any bio/pharma company committed to maintaining the highest standards of safety and risk management. As regulators increase PV audits and inspections, placing greater scrutiny on PV quality management systems, it’s up to the sponsor to assess internal activities, vendor relationships, commercial partnerships, and others that compromise the PV system.This year, at ExL’s 2nd Pharmacovigilance Audit and Inspection Conference will focus on the best practices and strategies for those preparing for their audit and inspection, educating PV professionals on new technologies and innovative methods in pharmacovigilance that are emerging, and how to utilize them to improve organizational performance and reporting.

CONFERENCE CHAIR

Kevin P. Malobisky, Ph.D., M.S., RAC,
Senior Vice President Global Regulatory, Affairs, Quality and Compliance,
ACHILLION PHARMACEUTICALS

“Truly a wonderful, well structured, and specific conference!”
—Director, Safety Science and Compliance,
TESARO

Top Five Reasons to Attend

  1. Examine complex issues such as managing large-scale data sets, facilitating cross-departmental PV engagement, developing detailed audit plans, generating timely and insightful reports, and tracking ever-evolving global regulationsUnderstand how to strategically solve challenges you are currently facing in your PV audits and inspections
  2. Develop a robust PV system that ensures both quality and safety while reaching a continual state of PV audit readiness
  3. Review the pressing issues related to managing the growing volume and frequency of audits and inspections
  4. Analyze feedback of methodology from industry experts
  5. Understand how to strategically solve current challenges facing your PV audit and inspections

Who Should Attend

  • Pharmacovigilance/Drug Safety (QPPV)
  • Regulatory Affairs
  • Quality and Compliance
  • Medical Information
  • Risk Management
  • Compliance
  • Pharmacovigilance Auditors
  • Management Staff Responsible for Running Inspections
  • Employees (Directly and Indirectly) Involved in Inspections
  • Drug/Product Safety
  • Drug Development
  • Info
  • Clinical Pharmacology
  • Clinical Safety
  • Research and Development
  • Quality Assurance
  • Patient Safety
  • Signal Detection
  • Safety Surveillance
  • Outcome Research
  • Data Analysis
  • Epidemiology
  • Medical Affairs
  • Regulatory Affairs and Compliance
  • Information Technology
Startdate: 2019-03-25
End Date 2019-03-26

Description: Attend the 2nd Pharmacovigilance Audit and Inspections Conference to discover emerging technologies and innovative methods to improve audit and inspection outcomes, through risk assessment and quality assurance
Performer: ExL Events
Address : The 2nd Pharmacovigilance Audit and Inspections Conference