The Investigator in clinical research: roles and responsibilities

  • 2° EDITION: 11 April 2024
  • Online
  • Italian

Training overview

Conducting clinical trials within the clinical research center includes as a key person the “Investigator,” which is the figure who is responsible for the trial activities agreed upon with the Sponsor/CRO. The Investigator in clinical research has well-defined role and responsibilities, verified periodically through monitoring and/or Audit, designed to ensure the highest standard of the clinical research center. The training course ” The Investigator in clinical research: roles and responsibilities” will focus on the important aspects of the Investigator’s role and responsibilities (according to Chapter 4 of ICH GCP E6 (R2)), making it particularly useful for those who need to verify the standard of the clinical research center.

Key points of the training

  • General concepts
  • The Reference Standards
  • The Role of the Investigator
  • The responsibilities of the Investigator

09:00 – 13:00 COURSE SESSION

  • The Investigator according to Chapter 4 of the ICH GCP E6 (R2)
  • The Investigator’s team
  • The possible errors of the Investigator
  • The importance of monitoring the experimental center

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.

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
250€
280€
Early Bird 5%
Within 1 month before the start of the training
265€
280€
Full price

280€

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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