Auditing Clinical Trials – module 1: an introduction to auditing clinical studies

  • 2° EDITION: 10 May 2024
  • Online
  • Italian

Training overview

What is auditing in clinical trials and why is it so important?

Conducting clinical trials is a complex activity, that involves adherence to standards predefined by a protocol, good clinical practices (GCPs), regulations, and all procedures applied before, during and after conducting the study. Auditing is a valuable ally and provides oversight apt to have a positive impact on the conduct of both simple and complex clinical trials.

The training course ” Auditing Clinical Trials – module 1: an introduction to auditing clinical studies” introduces concepts and methodologies that are indispensable for professionals working in the clinical research arena, who will benefit greatly from knowing about auditing and understanding its influence on the quality of their work.

This course is part of a cycle consisting of two modules. The second Module is “Auditing Course for Clinical Trials Module 2: In-depth life cycle auditing.”

If you buy both modules the price is 1150 €!

Key points of the training

  • General concepts and terminology
  • The Reference Standards for Auditing
  • Types of audits in quality management systems
  • The Phases of the auditing process

09:00 – 13:00 COURSE SESSION

  • General concepts
  • Historical context
  • Quality in clinical research
  • Competencies
  • Types of audits
  • Stages of the auditing process: scheduling, planning, and audit preparation

Clinical Research Sector: Quality Assurance, Monitor/CRA, Clinical Trial Assistant and Project Manager.

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.

Cancellation terms

In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

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.

Speakers

Oriella Nasta

Oriella Nasta

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.

Register now

Early Bird 10%
Within 2 months before the start of the training
495€
550€
Early Bird 5%
Within 1 month before the start of the training
520€
550€
Full price

550€

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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