The updated GCP ICH E6 (R2) Addendum is having an overall impact. This webinar explores what this means for you, your company and selected vendors.
The updated GCP ICH E6 (R2) Addendum requires companies to implement processes and procedures to meet its guidelines. If the FDA or EMA comes to do an inspection at your company, do you have your company procedures up to date?
The updated ICH E6 R2 in the form of an addendum to R1 was accepted by the FDA in March 2018. According to it, companies are required to put into place additional processes when conducting Clinical Studies and Operations. With an objective to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting, the guideline has been updated. It continues to emphasize the objectives of the research and ensure human subject protection and data integrity.
This webinar will review the changes noted in the ICH E6 R2 addendum and guide you and your company on the right path for reviewing and implementing processes to meet those guidelines.Areas Covered in the Webinar:
Review of ICH E6 R2 Addendum:
CCEO, PDG Clinical Consulting LLC
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.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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