Why Should You Attend:
With the adoption of the ICH E6 R2 addendum, companies are required to have processes and procedures to meet the updated guidelines. Are your company procedures up to date? What if the FDA or EMA came to do an inspection?
With the updating of ICH E6 R2 in the form of an addendum to R1, and acceptance by the FDA in in March 2018, additional processes need to be put into place when conducting Clinical Studies and Operations. The guideline has been updated to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting. All while continuing to stress the objectives of research and ensure human subject protection and data integrity.
This webinar will review the changes noted in the ICH E6 R2 addendum and point you and your company in the right direction for reviewing and implementing processes to meet those guidelines.
Areas Covered in the Webinar:
Review of ICH E6 R2 Addendum:
Why were these changes made?
Overall Addendum changes
What do these changes mean?
Areas that impact clinical operations
With the adoption of the ICH E6 R2 addendum, companies are required to have processes and procedures to meet the updated guidelines. Are your company procedures up to date? What if the FDA or EMA came to do an inspection?
With the updating of ICH E6 R2 in the form of an addendum to R1, and acceptance by the FDA in in March 2018, additional processes need to be put into place when conducting Clinical Studies and Operations. The guideline has been updated to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting. All while continuing to stress the objectives of research and ensure human subject protection and data integrity.
This webinar will review the changes noted in the ICH E6 R2 addendum and point you and your company in the right direction for reviewing and implementing processes to meet those guidelines.
Areas Covered in the Webinar:
Review of ICH E6 R2 Addendum:
Why were these changes made?
Overall Addendum changes
What do these changes mean?
Areas that impact clinical operations
Speakers
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.
