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.
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:
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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