Complimentary Webinar:
Safety Operations Expert Panel Discussion: A New Approach to Ensuring Quality Safety Submissions the First Time

 

Tuesday, November 3, 2015
11am EDT / 4pm BST / 5pm CEST
(Duration: 60 minutes)

 

Poor quality ICSR data impacts the ability to conduct safety surveillance activities and forces regulators and independent groups to question the overall quality of the PV system. This has led to sponsors, both of innovators and generics, and outsourcing vendors to apply increasing levels of scrutiny to the quality of their data. The need for case correction may be identified much earlier in the process through the right combination of enabling tools, expertise, optimized processes coupled with a retrospective quality review process and proactive audits. This webinar will present best practices and recommendations that can be employed to improve case quality, avoid feedback from regulators and independent groups, and facilitate data accuracy for safety surveillance and signal detection.

Featured Topics:

  • Stakeholders involved in the assessment of ICSR quality, including their influence and impact
  • Consequences and impact of poor quality submissions
  • How to distinguish between critical errors that would result in resubmission from other errors
  • How sponsors can employ best practices for optimum oversight in an outsourced model
  • How the right mix of technology, tools and processes help facilitate the quality review process

Who should attend?

Professionals who work in the area of:

  • PV and Risk Management professionals, including safety/pharmacovigilance operations, aggregate reporting and signal detection
  • Quality Assurance and Audit professionals Regulatory Affairs professionals

Learning Objectives:

At the conclusion of this webinar, participants should be able to:

  • Discuss ICSR quality issues from the perspective of both regulators and biopharmaceutical companies
  • Identify best practices on how to assess case quality and case corrections requiring resubmissions
  • Assess the impact of resubmissions on safety surveillance
  • Compare guidelines and practices across organizations
  • Identify and be able to resolve challenges in an outsourced model