Webinar ID:   FDB3484

3-Hour Virtual Seminar on GCP ICH E6 R2 Addendum and Impact on Selection and Managing Vendors in Clinical Research

  08/10/2020, 01:00 PM   - Eastern Time (US/Canada)
  3 Hours

FDA Regulations and the updated ICH E6R2 addendum note more expansive requirements for vendor oversight including quality systems and risk management awareness. This does not mean after signing the contract, your team finds out they are not compatible with the vendor or the vendor cannot provide the full services needed for the study. The sponsor needs to have internal analyses and planning processes up front to define requirements for choosing the right vendor.

Sponsors are outsourcing more clinical research processes, and they need to have both the team and processes in place to bring on vendors and manage them to be compliant and ensure a cohesive team approach. Sponsors are now even more responsible for vendor oversight and performance, but how is this accomplished?

Seminar Agenda:

  • What do the Regulations mean?
  • What’s new with the ICH E6 R2 Addendum
  • Vendor oversight – Where do you start?
  • Vendor management as a team approach
  • Defining requirements
  • Quality insight and input
  • Pre-Qualification of a vendor
  • Use of Tools and Processes
  • Managing vendor performance

Who Should Attend:

  • CEOs
  • Contract VPs
  • Quality VPs
  • Clinical VPs
  • Contract Personnel
  • GXP
  • Clinical Managers
  • Quality Managers


Pam Dellea-Giltner

Pam Dellea-Giltner is CEO and principal auditor of PDG Clinical Consulting LLC. She has over 30 years of experience in all aspects of Clinical Research Operations. Experience includes Quality Assurance/GCPs, Pre-Inspection Readiness/Audit Reponses, Project Management, Phase I-IV, post marketing and epidemiology studies, Study Management, Vendor/CRO Set up and management.

She has held positions in both pharmaceutical and CRO companies including GCP Auditor, Project Manager, Clinical Research Associate, and Trial Manager.

Currently she is Chairman of the ACRP CCRA Examination Committee and has been a certified CCRA since 2009.