- 10 June 2024
Applications of the new ICH E6 (R3) in step 2b
Conducting clinical trials is a complex activity that involves knowledge of specific standardized documentation and involves multiple stakeholders and different organizations. From a documentation point of view, each trial is organized through a series of documents that are the basis of the activities and allow visualizing theoretical and practical aspects, which are useful for all the figures involved in the trial. Different types of studies require “Core Documents”, which are essential for the initial phase of the study. The teacher aims to create a mapping of the study in line with the appendix of the ICH E6 (R3) draft currently in step 2b.
Key points of the training
- General concepts and terminology of clinical trial documentation
- ICH steps and ICH timing E6 (R3)
- The Reference Standards of Clinical Trial Documentation
- The possible structuring of the study documentation
- The responsibilities of the figures involved
09:30 – 12:30 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION
A. Trial Master File: Core documents and Sponsor/CRO documents.
B. Center Study File: documentation specific to each trial center
C. Investigator Study File: documentation in charge of the experimental center
D. Pharmacy File: documentation from the hospital pharmacy
Clinical Research Sector:
- Quality Assurance, Monitor/CRA, Clinical Trial Assistant and Project Manager
- Study Coordinator and Experimental Center Staff
The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.
For online trainings the access link will be sent 2-3 days before the start of the training.
5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.
In order to cancel enrolment to an event, please email firstname.lastname@example.org within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
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If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.
Quality Assurance & Auditor - Independent Consultant
Graduated in Industrial Pharmacy in 2008 and operating for over 10 years in the pharmaceutical and cosmetic sector with strong experience in clinical studies and skills for the management of CRO pursuant to DM.15.11.2011. In January 2020 she became an Independent Consultant as QA & Auditor with experience in GxP and ISO in the pharmaceutical, cosmetic and food sectors. Expertise: Quality system management (SOP management, selection of training providers; implementation of audits and CAPA), according to GCP/GMP/ISO; Internal and external quality controls, AIFA audits and inspections; Support to CRA, Project Manager and Medical Director for Clinical Trials according to ICH GCP (E6) R2.
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